Serial No. Name of the Test Effdate CPT Code

Transcription

1 LIIST OF WAIIVED TESTS Serial No. Name of the Test Effdate CPT Code *+ 1 Acon Mission U120 Urine Analyzer for Dipstick 10/28/ QW Billrubin, Blood, Glucose, Ketone, Leukocytes, Nitrite, Protein, Specific Gravity, Urobilinogen, ph *+ 1 ARKRAY PocketChem TM Aution Sticks 10TA 12/06/ *+ 1 Bayer Clinitek 50 Urine Chemistry Analyzer 10/7/ QW automated *+ 1 Bayer Clinitek 50 Urine Chemistry Analyzer for 10/27/ QW Creatinine *+ 1 Bayer Clinitek 50 Urine chemistry analyzer for micro albumin Creatinine and HCG 9/30/ QW - HCG 82044QW - M 82570QW - C *+ 1 Bayer Clinitek Status Urine Chemistry Analyzer 9/7/ QW *+ 1 Bayer Diagnostics/MICROALBUSTIX TM Reagent Strips for Microalbumin Creatinine 2/16/ QW - M 82570QW - C *+ 1 Bayer Multistix Pro 10LS, Pro 11 and Pro 7G. Reagent dipstick or tablet non automated for qualitative creatinine 8/22/ QW *+ 1 Beckman Coulter Icon Microalb for urine Albumin 5/13/ QW *+ 1 Biosys Laboratories Optima II Urine Analyzer 9/27/ QW *+ 1 Biosys Laboratories Optima Urine Analyzer 11/25/ QW *+ 1 BioSys Laboratories, Inc. UriScan Optima II Urine 2/18/ QW Analyzer *+ 1 Chemstrip Mini UA 2/23/ QW *+ 1 Cole-Taylor Marketing Inc. CTI-120 Urine Strip Analyzer for Urine Qualitative Dipstick Bilirubin, Blood, Glucose, Ketone, Leukocytes, Nitrite, Protein, Specific Gravity, Urobilinogen and ph 6/3/ QW *+ 1 Consult diagnostics Urine Analyzer for Dipstick Blood, Glucose, Ketone, Leukocytes, Nitrite, Protein, Specific Gravity, Urobilinogen, ph, Bilirubin *+ 1 Diagnostic Chemical ImmunoDip TM Urinary Albumin Screen (Urine Dipstick) & (K022538) *+ 1 Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer for Dipstick Billrubin, Blood, Glucose, Ketone, Leukocytes, Nitrite, Protein, Specific Gravity, Urobilinogen, ph 10/17/08 8/29/ QW 8/29/02 10/28/ QW *+ 1 Diatech Diagnostic Uriscreen (for OTC use) 2/4/ QW 0 1 Dipstick or tablet urinalysis (non-automated) *+ 1 Genzyme Diagnostics OSOM ImmunoDIP Urinary 10/26/ QW Albumin Test *+ 1 Hypoguard Diascreen R 50 Urine Chemistry Analyzer 12/06/ QW *+ 1 Physician Sales & Service, Inc. PSS Select Urine 2/18/ QW 1

2 Analyzer *+ 1 RefuAHU120 Urine Analyzer for Dipstick Billrubin, 10/28/ QW Blood, Glucose, Ketone, Leukocytes, Nitrite, Protein, Specific Gravity, Urobilinogen, ph *+ 1 Roche Diagnostics Chemstrip Micral (Urine dipstick) 5/7/ QW for Micro albumin *+ 1 Roche Diagnostics Urisys 1100 Urine Analyzer 12/17/ QW *+ 1 Roche Diagnostics/Boehringer Mannheim Chemstrip 12/3/ QW 101 Urine Analyzer *+ 1 Siemens Clinitek 50 Urine Chemistry Analyzer for 09/14/ QW Dipstick Bilirubin, Blood, Glucose, Leukocytes, Nitrite, Protein, specific Gravity, Urobilinogen, ph, Ketone, Creatinine, Microalbumin *+ 1 Siemens Clinitek Status Urine Chemistry Analyzer for 03/05/ QW Microalbumin, Urine Qualitative Dipstick Bilirubin, Urine Qualitative Dipstick Blood, Urine Qualitative Dipstick Creatinine, Urine Qualitative Dipstick Glucose, Urine Qualitative Dipstick Ketone, Urine Qualitative Dipstick Leukocytes, Urine Qualitative Dipstick Nitrite, Urine Qualitative Dipstick ph, Urine Qualitative Dipstick Protein, Urine Qualitative Dipstick Specific Gravity *+ 1 Teco Diagnostics URITEK TC 101 Urine Strip Reader 3/10/ QW *+ 1 ThermoBiostar TM PocketChem TM UA 12/06/ *+ 1 Mediwatch urinrwatch Urine Analyzer for Urine 01/20/ QW Qualitative Dipstick Bilirubin, blood, glucose, ketone, leukocytes, nitrite, protein, specific gravity, urobilinogen, ph *+ 2 Aescher Hemaprompt 04/07/ QW *+ 2 Beckman Coulter Hemoccult ITC; and ICT 05/26/04 6/28/ QW *+ 2 Beckman Coulter Primary Care Diagnostics Gastroccult 8/30/ QW *+ 2 Care Diagtnostic Clarity IFOB Test for Fecal Occult 01/26/ QW Blood *+ 2 Clarity Hemosure One-Step Immunological Fecal 3/16/ Occult Blood Test *+ 2 CLIA Waived, Inc. Rapid Fecal Occult Blood Test 11/09/ QW *+ 2 Enterix Insure & Enterix Insure II Fecal Immunochemical Test for fecal occult blood 10/10/03 08/03/ QW Fecal Occult Blood *+ 2 Forsure One Step Fecal Occult Blood (FOB) Screen 05/16/ QW Card Test *+ 2 Germaine Laboratories Compliance Gold ifob 07/01/ QW (immunological fecal occult blood)test *+ 2 Healthcare Provider Direct OneStep Fecal Occult Blood 07/22/ QW (FOB) Screen Card Test *+ 2 ImmoCARE Fecal Occult Blood Test 4/22/ QW 2

3 *+ 2 Immunostics, Inc., hema-screen SPECIFIC 06/15/ QW Immunochemical Fecal Occult Blood Test *+ 2 InSure Quik Fecal Immunochemical Test 01/26/ QW *+ 2 Inverse Medical Clearview ifobt Complete Fecal 03/01/ QW Occult Blood *+ 2 OcculTech Fecal Occult Blood Rapid Test 09/22/ QW *+ 2 QuickVue ifob Test (Immunochemical Fecal Occult Blood) {Cassette} 11/09/ QW *+ 2 Select Diagnostics Immunochemical Fecal Occult 02/08/ QW Blood Test *+ 2 Teco Rapid Fecal Occult Blood (FOB) Card Test 08/09/ *+ 2 Consult Diagnostics Immunochemical Fecal Occult 07/08/ QW Blood Test (ifobt) for Fecal Occult Blood *+ 2 Princeton BioMeditech BioSign Immunochemical Fecal 07/08/ QW Occult Blood Test (ifobt) for Fecal Occult Blood *+ 2 BTNX Inc Rapid Response Fecal Immunochemical 10/04/ QW Test (FIT) for Fecal Occult Blood *+ 2 American IVD Biotechnology Services Inc. FOB/CRC 10/04/ QW Advanced+ for Fecal Occult Blood *+ 3 Luna Fertility Indicator for fern test, saliva 09/03/ *+ 3 O2 Unlimited Donna Ovulation Tester for waived status 08/26/ for the analyte fern test, saliva 0 3 Ovulation Test Visual color comparison tests for luteinizing hormone *+ 3 Stesans Maybe?Mom Mini Ovulation Microscope for 08/26/ waived status for the analyte fern test, saliva *+ 3 TCI Ovulation Tester TM Fern Test - Saliva 12/5/ Urine Pregnancy visual color comparison tests Erthrocyte Sedimentation Rate non automated *+ 6 Abbott i-stat 6+ Cartridge {Whole Blood} for 11/13/ QW Hemoglobin *+ 6 Abbott i-stat E3+ Cartridge {Whole Blood} for 11/13/ QW Hemoglobin *+ 6 Abbott i-stat EC4+ Cartridge {Whole Blood} for 11/13/ QW Hemoglobin *+ 6 Anemiapro Self Screener for hemoglobin 12/22/ QW *+ 6 Biotest Hemoglobin Measuring System 08/29/ QW *+ 6 Biotest Hemoglobin Measuring System for waived 08/29/ QW status for the analyte Hgb, single analyte instrument with self contained features *+ 6 EFK Diagnostic Hemo_Control Measurement, Hbg and 10/20/ QW Hemo_Control Microcuvettes *+ 6 GDS Diagnosis HemoSite Meter for Hemoglobin 10/30/ QW *+ 6 GDS Technology STAT-Site MHgb Test System 2/11/ QW *+ 6 Hemocue Donor Hemoglobin Checker System 5/14/ QW *+ 6 Hemocue HB 201 DM Analyzing System K /28/ QW *+ 6 Hemocue HB 201+System (Capillary, Venous, Arterial 6/30/ QW 3

4 Whole Blood) *+ 6 HemoCue Hb 301 System for hemoglobin 10/10/ QW *+ 6 Hemocue Hemoglobin 201+/Hemocue Microcuvette 05/04/ QW System *+ 6 HemoCue Plasma/Low Hb system for hemoglobin by 9/21/ QW single analyte instruments with self contained or component features to perform specimen/reagent interaction, providing direct measurement and readout. 1 *+ 6 Hemoglobin by single analyte instruments with selfcontained 85018QW or component features to perform specimen/reagent interaction, providing direct measurement and readout 0 6 Hemoglobin Copper Sulfate non automated *+ 6 Stanbio Hemoglobin Analyzer 6/9/ QW *+ 6 Stanbio HemoPoint H2 Hemoglobin Measurement 6/9/ QW System *+ 7 Abbott i-stat 6 + Cartridge {Whole Blood} for 11/13/ QW Hematrocrit *+ 7 Abbott i-stat E3+ Cartridge {Whole Blood} for 11/13/ QW Hematrocrit *+ 7 Abbott i-stat EC4+ Cartridge {Whole Blood} for 11/13/ QW Hematrocrit *+ 7 Micro Diagnostics Spuncrit Model DRC 4 Infrared 2/23/ QW Analyzer 0 7 Spun Microhematocrit *+ 7 Ultracrit for hematocrit 08/09/ QW *+ 7 Wampole STAT CRIT HCT 3/4/ QW *+ 8 Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc){whole blood} for 10/04/06 Pending alkaline phosphatase (ALP) and amylase. *+ 8 Abaxis, Piccolo xpress Chemistry Analyzer for triglyceride, cholesterol and HDL *+ 8 Abaxix Piccolo Blood Chemistry Analyzer (Piccolo Metlyte 8 Panel Reagent Disc) {whole blood} for Chloride, Glucose, Creatinine, Potassium, Urea (BUN), Creatine Kinase (CK), Carbon Dioxide, Total (CO2), Sodium *+ 8 Abaxix Piccolo Blood Chemistry Analyzer (Piccolo Renal Function Panel) { whole blood} for Chloride, Phosphorous, Albumin, Creatinine, Urea (BUN), Glucose, Calcium, Total, Potassium, Carbon Dioxide, Total CO2,, Sodium *+ 8 Abaxix Piccolo xpress Chemistry Analyzer (Kidney Check Panel) {Whole Blood} for Urea (BUN) and Creatinine 01/22/ QW-C 84478QW-T 83718QW-HDL 12/04/08 Pending 12/04/08 Pending 08/09/07 Pending *+ 8 Abaxix Piccolo xpress Chemistry Analyzer (Piccolo 12/04/08 Pending 4

5 Metlyte 8 Panel Reagent Disc) {whole blood} for Chloride, Glucose, Creatinine, Potassium, Urea (BUN), Creatine Kinase (CK), Carbon Dioxide, Total (CO2), Sodium *+ 8 Abaxix Piccolo xpress Chemistry Analyzer (Piccolo 12/04/08 Pending Renal Function Panel) {whole blood} for Chloride, Phosphorous, Glucose, Albumin, Creatinine, Urea (BUN), Calcium, Total, Potassium, Carbon Dioxide, Total (CO2), Sodium *+ 8 Accu-Chek Instant Plus Cholesterol test system 5/20/ QW *+ 8 Accutech CholesTrak HDL Cholesterol Home Test 01/08/ QW-C *+ 8 Actimed Laboratories ENACT Total Cholesterol Test & ENACT Total Cholesterol Test 12/3/98 12/19/ QW 82465QW *+ 8 Advanced Care for Cholesterol monitoring - Mfr 82465QW Johnson & Johnson *+ 8 Biomedix Inc.Qsteps Biometer G/C Dual Monitoring System for cholesterol and glucose 8/11/ QW-C 82947QW-G *+ 8 Blood cholesterol test by monitoring devices approved for home use by FDA 82465QW *+ 8 ChemTrak AccuMeter for Cholesterol 82465QW *+ 8 Cholestech LDX (Lipid Profile ALT (GPT) for triglyceride, HDL cholesterol and alanine aminotransferase 05/16/ QW-C 83718QW-HDL 84478QW-T *+ 8 Cholestech LDX system for total cholesterol, HDL Cholesterol, triglycerides, glucose and Alanine Ammotransferase (ALT) Analyte Aspartate Aminotransferase (AST) (SGOT) *+ 8 Infopia USA LipidPro lipid profile and glucose measuring system (LipidPro Lipid Profile test strips for Cholesterol, HDL Cholesterol and Triglyceride 4/13/01 6/18/ QW-ALT 82465QW - C 83718QW - HDL 82947QW - G 80061QW - LP 84478QW - T 84460QW - ALT 84450QW- AST 12/2/ QW-C 83718QW-HDL 84478QW-T *+ 8 Infopia USA LipidPro lipid profile and glucose 12/2/ QW measuring system for Glucose, Cholesterol, HDL Cholesterol, Triglyceride *+ 8 Lifestream Tech Personal Cholesterol Monitor 7/21/ QW *+ 8 Lifestream Technologies Cholesterol monitor 2/24/ QW *+ 8 Lifestream Technologies Lifestream Plus Cholesterol 06/01/ QW Monitor *+ 8 Piccolo Point of Care Chemistry Analyzer (Lipid Panel 7/9/ QW Reagent Disc) (whole blood) for the analytes cholesterol, HDL cholesterol and triglyceride *+ 8 Polymer Technology Systems Bio Scanner (for OTC 1/13/ QW 5

6 use) HDL & 2000 PTS (K996247/A004) & (K993377/A008) *+ 8 Polymer Technology Systems Bioscanner Plus (PTS Panels Lipid Panel Test Strips) *+ 8 Polymer Technology Systems Bioscanner Plus PTS Panels Lipid Strips *+ 8 Polymer Technology Systems Cardiocheck Analyzer & Cardiocheck PA Analyzer (PTS Panels Lipid Panel Test Strips) *+ 8 Polymer Technology Systems Cardiocheck Analyzer, PA Analyzer & Bioscanner Plus (PTS Panels Chol+Glu Test Panel) *+ 8 Polymer Technology Systems Cardiocheck Brand Analyzer (PTS PANELS for Cholesterol and HDL Cholesterol) +* 8 Polymer Technology Systems CardioCheck PA PTS Lipid Panel Strips for cholesterol, HDL cholesterol and triglycerides *+ 8 Polymer Technology Systems CardioChek Analyzer & PA Analyzer for PTS PANELS HDL Cholesterol Test Strips *+ 8 Polymer Technology Systems CardioChek analyzer & Polymer Technology Systems CardioChek PA analyzer (PTS Panels CHOL+HDL Test Panel Test Strips *+ 8 Polymer Technology Systems CardioChek Brand Analyzer (PTS Panels for Cholesterol, HDL and Glucose) *+ 8 Polymer Technology Systems CardioChek PA Analyzer (PTS Panels for Cholesterol, HDL and Glucose panel test strips *+ 8 Polymer Technology Systems CardioChek PA Analyzer (PTS PANELS Metabolic Chemistry Panel Test Strips) for glucose, HDL Cholesterol and triglyceride *+ 8 Polymer Technology Systems Cardiochek PA Analyzer and the Polymer Technology Systems Cardiochek Brand Analyzer for LDL cholesterol *+ 8 Polymer Technology Systems Inc. Bio Scanner & 2000 PTS test strips for Triglycerides (for OTC use) *+ 8 Polymer Technology Systems, Inc. BioScanner Test strip Cholesterol & 2000 PTS Panels & ( +K981493/A003) *+ 8 Roche Diagnostics Accuchek Instant Plus Dual Testing System for cholesterol and glucose *+ 8 Wako APOLOWAKO Analyzer for Cholesterol, Triglyceride, Glucose *+ 9 Abaxis Piccolo Blood & xpress Chemistry Analyzer (General Chemistry 13 & 6 panel) {Whole Blood} Urea 06/25/02 11/21/ QW 10/18/ QW 11/21/ QW 2/15/ QW - C 82947QW - G 10/15/ QW-C 83718QW-HDL 10/18/ QW 83718QW 84478QW 04/10/ QW 9/27/ QW-C 83718QW -H 82465QW-C 83718QW-HDL 82947QW-G 06/01/ QW-C 83718QW-HDL 82947QW-G 02/07/ QW-HDL 82947QW-G 84478QW-T 3/25/05 Pending 07/06/00 04/30/02 4/3/00 6/25/ QW 82465QW 8/24/ QW-C 82947QW-G 10/31/08 Pending 03/14/08 Pending 84460QW-GGT 6

7 (BUN), Creatinine, Albumin, AST, Glucose, GGT *+ 9 Abaxis Piccolo Blood & xpress Chemistry Analyzer (General Chemistry 13 panel) {Whole Blood} for total protein and total Bilirubin *+ 9 Abaxis Piccolo Blood & xpress Chemistry Analyzer (Comprehensive & Basic Metabolic Reagent Disc) {Whole Blood} for AST, total Bilirubin, total protein, albumin, glucose, creatinine, BUN *+ 9 Abaxis Piccolo Blood Chemistry Analyzer (General Chemistry 13 Panel) {Whole Blood} for analytes uric acid, urea, creatinine and total calcium *+ 9 Abaxis Piccolo Point of Care Chemistry Analyzer (Lipid Panel Reagent Disc) (Whole Blood) for alanine aminotransferase (ALT)(SGPT) *+ 9 Abaxis Piccolo Point of Care Chemistry Analyzer (Lipid Panel Reagent Disc) (Whole Blood) for aspartate aminotransferase (AST)(SGOT) and glucose *+ 9 Abaxis Piccolo Point Of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) {whole blood} for total bilirubin, albumin and total protein. *+ 9 Abaxis Piccolo xpress Chemistry Analyzer (General Chemistry 13 panel) {Whole Blood} for analytes uric acid, urea, creatinine and total calcium *+ 9 Abaxis, Piccolo xpress Chemistry Analyzer for albumin, AST, glucose, total bilirubin, total protein, GGT,ALT, ALP and Amylase *+ 9 Abaxix, Piccolo blood & xpress Chemistry Analyzer (Comprehensive, Electrolyte & Basic Metabolic Reagent Disc) {Whole Blood} for Sodium, Chloride, Carbon Dioxide, Potassium *+ 9 Abaxix, Piccolo xpress Chemistry Analyzer (Lipid Panel Plus Reagent Disc) {Whole Blood} for Glucose, AST, Cholesterol, ALT, Triglyceride, HDL Cholesterol *+ 9 Abaxix, Piccolo xpress Chemistry Analyzer (Lipid Panel Reagent Disc) for Cholesterol, Triglyceride, HDL Cholesterol *+ 9 Abaxix, Piccolo xpress Chemistry Analyzer (Liver Panel Plus) {Whole Blood} for Total Protein, Total Bilirubin, AST, Albumin, Amylase, ALP, ALT *+ 9 Abaxix, Piccolo xpress Chemistry Analyzer (Liver Panel Plus) for GGT *+ 9 Abbott I STAT CHEM8+ Catridge {whole blood} for Calcium, Ionized, Carbon Dioxide, Chloride, Creatinine, Glucose, Hemoglobin, Hematocrit, Potassium, Sodium and Urea (BUN) 03/14/08 Pending 01/15/08 Pending 03/14/07 Pending 8/16/ QW 8/16/ QW-G 84450QW-AST 10/04/06 Pending 03/14/07 Pending 01/22/ QW-G 84450QW-AST 84460QW-ALT TB,TP,GGT,ALP, Amylase (Pending) 06/25/ QW 80051QW, 80048QW 04/14/08 Pending 04/14/ QW, 84478QW, 80061QW 04/14/08 Pending 03/14/08 Pending 09/02/ QW,82330 QW, 82374QW, 82435QW 7

8 *+ 9 Abbott i-stat 6 + Cartridge {Whole Blood} for 11/13/08 Pending Sodium, Urea (BUN), Chloride, Potassium *+ 9 Abbott i-stat 6+ Cartridge {Whole Blood} Glucose 11/13/08 Pending *+ 9 Abbott i-stat Cartridge {Whole Blood} for Glucose 11/13/08 Pending *+ 9 Abbott i-stat Crea Cartridge {Whole Blood} for 11/13/08 Pending Creatinine *+ 9 Abbott i-stat E3+ Cartridge {Whole Blood} for 11/13/08 Pending Sodium and Potassium *+ 9 Abbott i-stat EC4+ Cartridge {Whole Blood} for 11/13/08 Pending Glucose, Sodium, Potassium *+ 9 Abbott Laboratories, Medisence Products Precision TM 2/28/ Xtra TM Advanced Diabetes Management System for ketone *+ 9 Abbott Medisense Precision Xtra Advanced Diabetes 4/15/ Management System *+ 9 Abbott Precision Xceed Pro Blood Glucose and B- 10/17/08 Pending Ketone Monitoring System *+ 9 Arkray SPOTCHEM EZ Chemistry analyzer (Spotchem II Basicpanel 1) {whole blood} for the analytes glucose, urea (BUN), creatinine, albumin and total calcium 05/31/ QW G Urea Pending Creatinine Pend Calcium - Pend *+ 9 Arkray SPOTCHEM EZ Chemistry Analyzer {whole 10/05/06 Pending blood) for (BUN) *+ 9 Arkray SPOTCHEM EZ Chemistry Analyzer {whole 05/31/07 Pending blood} for the analyte total protein *+ 9 Arkray SPOTCHEM EZ Chemistry Analyzer for 7/12/ QW-G alanine aminotransferase (ALT) (SGPT) and glucose *+ 9 Arkray SPOTCHEM EZ Chemistry Analyzer for creatinine ALP, AST, total bilirubin, total protein and ALT 84460QW-ALT 05/31/ QW-ALP 84460QW-ALT (ALP, TB, TP- Pending) 0 9 Blood Glucose by monitoring device approved for home use by FDA *+ 9 Cygnus Inc. GlucoWatch Automatic Glucose 3/28/ Biographer *+ 9 HemoCue Albumin 201 System Albumin Urinary 06/13/08 Pending *+ 9 HemoCue B-Glucose Photometer 10/1/ *+ 9 Hemocue Glucose 201 DM Analyzer 9/28/ *+ 9 HemoCue R Glucose 201 Microcuvettes and Glucose 07/19/ Analyzer, K020935/A1 for glucose *+ 9 Home Diagnostics Medline Blood Glucose System 11/08/ *+ 9 Home Diagnostics ShopRite Flood Glucose System IQ 11/08/ *+ 9 LXN Duet Glucose Control Monitoring System 12/17/ *+ 9 Nova Biomedical Nova Max Plus Glucose and B- Ketone Monitoring System for Glucose and Blood Ketone 03/02/ QW 8

9 *+ 9 Piccolo Point of Care Chemistry Analyzer (Lipid Panel 04/14/08 Pending Plus Reagent Disc) {Whole Blood} for Cholesterol, HDL Cholesterol, Triglyceride *+ 9 Piccolo Point of Care Chemistry for Triglyceride 04/01/08 Pending *+ 10 Abbott FlexPak HP Test for whole blood 4/7/ QW *+ 10 Abbott Laboratories Signify H. Pylori Cassette {Whole 09/11/ QW Blood} *+ 10 Abbott Test Pack Plus H.pylori (for whole blood) 4/27/ QW *+ 10 ACON Helicobacter pylori Rapid Test Device 3/23/ QW *+ 10 Alfa Scientific Designs Instant View H. Pylori Whole 2/1/ QW Blood Rapid Test *+ 10 Applied Biotech,Inc. SureStrep TM H.pylori WB Test 11/1/ QW *+ 10 ARJ Pylo-Plus Urease Test (H. Pylori detection) for 01/20/ QW Helicobacter Pylori *+ 10 Ballard Medical Products CLOtest 87077QW *+ 10 Becton Dickinson Link2 H. pylori Rapid Test (whole 4/27/ QW blood) *+ 10 Boehringer Mannheim Accu Stat H pylori One step (for 12/3/ QW whole blood) *+ 10 BTNX Inc. Rapid Response H. Pylori Whole Blood 01/16/ QW Rapid Test Device *+ 10 Cardinal Health SP Brand Rapid Test H. Pylori 1/13/ QW *+ 10 Cardinal Health SP Brand Test H.Pylori {whole blood) 05/24/ QW *+ 10 Chemtrak Accumeter H pylori Test (for whole blood) 86318QW *+ 10 Clarity H. Pylori Rapid Test Device {whole blood} 10/20/ QW *+ 10 DE Healthcare Products Truview H.pylori Test 10/29/ QW *+ 10 Delta West Clotest 2/26/ QW *+ 10 Diagnostic Test Group Clarity H Rapid Test Device 12/17/ QW {Whole Blood} *+ 10 EarlyDETECT H PYLORI WHOLE BLOOD RAPID 05/21/ QW TEST *+ 10 Fisher Healthcare Sure-Vue H.pylori Test {Whole 06/11/ QW Blood} *+ 10 FLEXSURE HP test for IgG Antibodies to H.pylori 3/17/ QW (whole blood) *+ 10 Germaine Laboratories, AimStep H.pylori (whole 12/9/ QW blood) *+ 10 GI Supply HP FAST 3/28/ QW *+ 10 GI Supply, Div. Chek-Med Systems HP One for H 3/24/03 pylori *+ 10 Henry Schein One Step + H. Pylori Test Device (whole 07/25/ QW blood) {H. Pylori) *+ 10 Henry Schein One Step+ H Pylori Rapid Test Device 07/25/ QW (whole blood) {H.Pylori) *+ 10 Henry Schein OneStep+ H. pylori Test 10/29/ QW *+ 10 Immunostics Detector H. pylori WB (H. pylori antibody Test {for whole blood) 05/16/ QW 9

10 *+ 10 Instant Technologies Iscreen H.Pylori Rapid Test 9/27/ QW Device *+ 10 Inverness Medical Clearview H.pylori Test {Whole 03/07/ QW Blood} *+ 10 Inverness Medical Signify H. Pylori Whole Blood 05/21/ QW *+ 10 Jant Pharmacal Accutest H. Pylori Rapid Test Device 11/26/ QW {Whole Blood} *+ 10 JANT Pharmacal Corp. H. pylori (WB Test) 4/13/ QW *+ 10 LifeSign H. pylori WB (for whole blood) 6/3/ QW *+ 10 McKesson Medi-Lab Performance H.pylori {Whole 06/11/ QW Blood} *+ 10 Medical Instruments Corporation Pronto Dry H.pylori 8/30/ QW *+ 10 Meridian Bioscience ImmunoCard STAT H pylori (for 08/09/ QW whole blood) *+ 10 Meridian Bioscience Immunocard STAT!H p SA (Stool) 5/31/ QW for H. Pylori *+ 10 PerMaxim RadiScreen H. pylori Test Device (whole 4/26/ QW blood) *+ 10 Polymedco,Inc.Poly stat H.pylori for whole blood 4/13/ QW *+ 10 Princeton BioMeditech BioSigh H.Pylori WB (for 6/2/ QW whole blood) *+ 10 Pro-Advantage by NDC H.Pylori Device (Whole 08/24/ QW Blood) for Helicobacter Pylori Antibodies *+ 10 Quick Vue One-Step Helicobacter pylori test for whole 10/31/ QW blood *+ 10 Quidel Quickvue one step H. pylori II Test (for whole 8/27/ QW blood) *+ 10 Remel RIM A.R.C. H. pylori Test 5/16/ QW *+ 10 Select Medical Products Brand Rapid Test H. Pylori 06/25/ QW {Whole Blood Only} (H.Pylori) *+ 10 Serim Pyloritex Test Kit & Serim Pyloritex VP Test Kit 2/21/ QW 5/08/02 *+ 10 Trinity Uni-Gold TM H. pylori 7/11/ QW *+ 10 Wampole Laboratories Clearview H.pylori II 3/8/ QW (fingerstick or whole blood) *+ 10 Accutest H pylori Rapid Test-Serum (Dip Strip) (Jant 10/04/ QW Pharmacal) for Helicobacter Pylori *+ 10 Stanbio RELY H.pylori Rapid Test (whole blood) 04/07/ QW (Finger stick only) for Helicobacter Pylori Antibodies *+ 11 Abbott Laboratories Signify Strep A Dipstick 07/07/ QW *+ 11 Abbott Signify Strep A Test 9/22/ QW *+ 11 ACON Strep A Twist Rapid Test 06/12/ QW *+ 11 Acon R Strep A Rapid Test Strip 12/18/01 *+ 11 Applied Biotech Sure Step Strep A (II) (Direct from 1/28/ QW throat swab) *+ 11 Beckman Coulter ICON DS Strep A Test 10/29/ QW *+ 11 Beckman Coulter ICON SC Strep A Test 08/06/ QW 10

11 *+ 11 Beckman Coulter Primary Care Diagnostics ICON DS 12/18/01 Strep A *+ 11 Beckman Coulter Primary Care Diagnostics ICON Fx 3/16/ QW Strep A Test *+ 11 Beckman Coulter Primary Care Diagnostics ICON SC 09/25/23 Strep A Test *+ 11 Becton Dickinson Link 2 Strep A Rapid Test (direct 7/24/ QW from throat) *+ 11 Binax Now Strep A Test 1/10/ QW *+ 11 Bio-Star Acceava Strep A Test Direct specimen 7/16/ QW *+ 11 Biotechnostix Rapid Response Strep A Rapid Test 4/21/ QW Device & Rapid Test Strip *+ 11 Cardinal Health SP Brand Rapid Test Strep A Cassette 1/25/ QW & Dipstick *+ 11 Cardinal Health SP Brand Rapid Test Strep A Dipstick 05/24/ QW *+ 11 Clearview Strep A Exact Dipstick 7/26/ QW *+ 11 CLIA Waived Inc. Rapid STREP A Test 09/15/ QW *+ 11 Consult Diagnostics STREP A RAPID Dipstick 04/01/ QW *+ 11 DE Healthcare Products TruView Strep A Cassette & 10/29/ QW dipstick *+ 11 DE Healthcare Products TruView Strep A Cassette Test 4/15/ QW *+ 11 DE Healthcare Products Truview Strep A Dipstick Test 10/29/ QW *+ 11 DE Healthcare Products TruView Strep A Test 10/23/ QW *+ 11 Diagnostic Test Group Clarity Strep A Rapid Test 04/08/ QW Strips *+ 11 Fisher HealthCare Sure-Vue Strep A 9/22/ QW *+ 11 Genzyme contrast Strep A 10/30/ QW *+ 11 Genzyme OSOM Strep A Ultra Test (25 Test Kit Size) & K992658/A009 (50 Test Kit) 07/19/02 7/15/ QW 87880QW *+ 11 Germaine Laboratories Strep AIM Tower for 12/21/ QW Streptococcus Group A *+ 11 Germaine Laboratories StrepAim Rapid Dipstick Test 10/21/ QW *+ 11 Henry Schein Inc. One Step+Strep A Test & Dipstick 10/23/ QW Test 10/29/04 *+ 11 Henry Schein One Step+Strep A Cassette Test 01/17/ QW *+ 11 Henry Schein One Step+Strep A Dipstick Test 07/17/ QW *+ 11 IMI Signify Strep A Dipstick 05/21/ QW *+ 11 IMI Signify Strep A Dipstick (Inverness Medical 05/21/ QW Innovation) *+ 11 Immunostics Detector Strep A 6/28/ QW *+ 11 Immunostics Immuno/Strep A 02/13/ QW *+ 11 Instant Technologies, Istrep & One Step Strep A 7/3/03 & 87880QW 9/25/03 *+ 11 Inverness Medical BioStar Acceava Strep A Twist 03/19/ QW (StrepA_ *+ 11 Inverness Medical Clearview Strep A Exact II Dipstick 02/08/ QW 11

12 *+ 11 Inverness Medical Signify Strep A Cassette (Inverness 05/21/ QW Medical Innovation) *+ 11 Jant Pharmacal AccuStrep A (II) Direct from throat 87880QW swab *+ 11 Jant Pharmacal Accustrip Strep A Value + Test Strip for 07/07/ QW Strep A *+ 11 Jant Pharmacal Accutest Integrated Strep A Rapid test 03/19/ QW Device (StrepA) *+ 11 Jant Pharmacal Corp Clinipak Strep A Rapid Test Strip 6/28/ QW *+ 11 Laboratory Supply Company (LSC) PEP Strep A 10/29/ QW Cassette Test & Dipstick Test *+ 11 LifeSign LLC Status Strep A Test 5/17/ QW *+ 11 Mainline Confirm Strep A DOT Test 9/2/ QW *+ 11 McKesson Medi-Lab Performance Strep A Test Twist 05/10/ QW *+ 11 McKesson Medi-Lab Performance Strep A Test 3/8/ QW Cassette & Test Dipstick *+ 11 Mckesson Medi-Lab Strep A Test Dipstick 03/28/ QW *+ 11 McKesson Strep A Test Cassette 12/13/ QW *+ 11 Medi-Lab Performance STREP A TWIST RAPID 03/28/ QW TEST *+ 11 Meridian Diagnostics ImmunoCard Stat Strep A 5/19/ QW *+ 11 Moore Medical The Supply Experts Strep A Rapid Test 07/07/ QW Dipstick *+ 11 Moore Medical The Supply Experts Strep A Test 03/19/ QW Cassette (Strep A) *+ 11 PEP Performance Enhanced Products Strep A Cassette 9/16/ QW Test and Strep A Dipstick *+ 11 Permaxim Rediscreen Strep A Rapid Test 07/02/ QW *+ 11 PerMaxim RediScreen Strep A Twist Cassette 05/10/ QW *+ 11 Polymedco Poly Stat Strep A Dipstick 07/07/ QW *+ 11 Polymedco Poly Stat Strep A Liquiud Test 6/4/ QW *+ 11 Polymedco, Inc.Poly stat A (II) Direct from throat swab 4/13/ QW *+ 11 Princeton BioMediTech BioStrep A Test & Status First Strep+A 5/17/00 1/19/ QW 87880QW *+ 11 PSS World Medical Select Diagnostics Strep A 07/07/ QW Dipstick *+ 11 PSS World Medical Select Diagnostics Strep A Twist 06/28/ QW *+ 11 QuickVue R Dipstick StrepA for Group A Streptococcus 7/27/ QW *+ 11 Quidel QuickVue R in line Strep A Test applies only 3/7/ QW to 25 test (Trade Name Change) 7/8/02 *+ 11 RAC Medical Clarity Strep A Twist Rapid Test Device 4/21/ QW & Test Strips *+ 11 Remel Rim ARC Strep A Test (direct from throat swab) 2/28/ QW *+ 11 SA Scientific SAS Strep A 2/2/ QW *+ 11 Sacks Medical Refuah Strep A Rapid Test 07/08/ QW *+ 11 Select Medical Products Brand Rapid Test Strep A 06/25/ QW 12

13 Dipstick *+ 11 Signify Strep A Dipstick 1/10/ QW *+ 11 Stanbio Qustick A for Strep A 03/05/ QW *+ 11 Wyntek OSOM ultra Strep A Test 5/1/ QW *+ 11 Wyntex Diagnostic OSOM Strep A Test 3/28/ QW *+ 11 PSS Consult Diagnostics Strep A Dipstick 08/18/ QW *+ 11 BTNX, Inc Strep A Rapid Test for Streptococcus, 10/04/ QW Group A *+ 11 Acceava Strep A Test for Streptococcus, Group A 12/17/ QW *+ 11 ProAdvantage by NDC Strep A Test 04/21/ QW *+ 11 BTNX Rapid Response Strep A Rapid Test Strips 02/02/ QW *+ 12 Acceava Mono II {Whole Blood} 04/14/ QW *+ 12 ACON Mononucleosis Rapid Test Strip (Whole Blood) 9/1/ QW & ACON Mononucleosis Rapid Test Device (Whole Blood) *+ 12 Applied Biotech One Step + Mono Test 10/15/ QW *+ 12 Applied Biotech SureStep Monotest (whole blood) 1/7/ QW *+ 12 Applied Biotech Truview Mono Test 10/15/ QW *+ 12 BioStar Acceava Mono II {whole blood} 11/01/ QW *+ 12 Bio-Star Acceava Mono Test (whole blood) 6/25/ QW *+ 12 Cardinal Health, SP Brand Rapid Test Mono {Whole 05/31/ QW Blood} *+ 12 Clarity MONO Mononucleosis Rapid Test {Whole 12/17/ QW Blood) *+ 12 Clearview MONO Whole Blood {whole blood} 04/12/ QW *+ 12 Clearview Mono-plus II 3/8/ QW *+ 12 Genzyme Contrast Mono (whole blood) 1/28/ QW *+ 12 Genzyme OSOM Mono Test 3/6/ QW *+ 12 Genzyme Sure-Vue Signature MONO Test {Whole 02/22/ QW Blood} *+ 12 Henry Schein One Step + Mono Test 07/12/ QW *+ 12 Henry Schein One Step + Mononucleosis Rapid Test 02/26/ QW Device {Whole Blood) *+ 12 Icon Mono 1/24/ QW *+ 12 Immuno Detector BioSign Mono WB (whole blood) 03/21/ QW *+ 12 Immuno Detector Mono {Whole Blood} 05/17/ QW *+ 12 Instant Technologies iscreen Mononucleosis Rapid Test 9/27/ QW Strip {Whole blood} & Instant Technologies iscreen Mononucleosis Rapid Test Device {Whole blood} *+ 12 Jant Accutest Infectious Mononucleosis (whole blood) 5/18/ QW *+ 12 Jant Pharmacal Accutest Value + Mononucleosis Rapid 01/08/ QW Test {Whole Blood} *+ 12 Life Sign Unistep Mono Test (whole blood) 7/9/ QW *+ 12 LifeSign Status Mono {for whole blood} 11/22/ QW *+ 12 McKesson Medi-Lab Performance Infectious Mononucleosis Test {For whole blood} for Infectious Mononucleosis Antibodies (Mono) 03/31/ QW 13

14 *+ 12 McKesson Medi-Lab Performance Mononucleosis Test 3/22/ QW *+ 12 Medi-Lab Performance Infectious Mononucleosis Test 04/12/ QW {whole blood} *+ 12 Meridien ImmunoCard STAT Mono (for whole blood) 86308QW *+ 12 PerMaxim RediScreen Mononucleosis {Whole Blood} 07/27/ QW *+ 12 Polymedco, Inc. Poly stat Mono for whole blood 4/13/ QW *+ 12 Princeton BioMeditech Biosign Mono WB 4/17/ QW *+ 12 Quidel cards 0.S Mono (for whole blood) 9/30/ QW *+ 12 Quidel QuickVue+Infectious Mononucleosis (whole 12/18/ QW blood) *+ 12 RAC Medical Clarity Mono Mononucleosis Rapid Test 02/22/ QW Device {Whole Blood} *+ 12 Rapid Response Mononucleosis Rapid Test Device 12/15/ QW (Whole Blood) *+ 12 Remel Rim ARC Mono Test (whole blood) 2/28/ QW *+ 12 Seradyn Color Q Mono (whole blood) 86308QW *+ 12 Signify Mono Test 1/10/ QW *+ 12 Signify Mono Whole Blood & cassette {whole blood) 04/12/ QW 07/12/07 *+ 12 SP Brand Rapid Test Mono 1/10/ QW *+ 12 Stanbio Rely Mono Rapid Test {Whole Blood} 01/08/ QW *+ 12 Wampole Mono-Plus (whole blood) 12/27/ QW *+ 12 Wyntek Diagnostic OSOM Mono Test(whole blood) 4/17/ QW *+ 12 Wyntek Signify Mono Test (whole blood) 9/7/ QW *+ 12 Consult Diagnostics Mononucleosis Cassette {whole 10/04/ QW blood) for Infectious Mononucleosis Antibodies (Mono) *+ 13 AvoSure PT System (Prescription home use & 2/16/ QW Professional Use) for Prothrombin time *+ 13 Coagu Check PST (Patient Self Test) for Prothrombin 9/22/ QW Time *+ 13 CoaguSense Self-Test Prothrombin Time/INR 4/15/ QW Monitoring System (Prescription Home Use) for Prothrombin Time (PT) *+ 13 Hemosense INRATIO System for prothrombin time 12/03/ QW (PT) *+ 13 International Technidyne Corporation Microcoagulation 8/29/ QW (without program plug) *+ 13 International Technidyne Protime Microcoagulation 7/23/ QW System (Protime 3 Cuvette) for Prescription Home Use and for Professional Use *+ 13 Lifescan Harmony INR Monitoring System 12/02/ QW (Prescription Home use and Professional use) *+ 13 Lifescan Rubicon Protrohombin Time Monitoring 8/17/ QW System (Prescription Home Use and Professional Use) *+ 13 Roach Diagnostics CoaguCheck XS Plus PST System 03/09/ QW *+ 13 Roche Diagnostics Coagu Check S. Systems Test for Prothrombin Time & PT-S (K020831) 9/6/ QW 14

15 *+ 13 Roche Diagnostics CoaguCheck XS PST for 02/26/ QW prothrombin time *+ 13 Roche Diagnostics CoaguChek XS 03/23/ QW *+ 13 Roche/Boehringer Mannheim CoaguCheck system for 10/27/ QW Professional use & PT-S (K021190) *+ 14 Axis-Shield Afinion AS100 Analyzer for Hgb A1 c 02/17/ QW *+ 14 Bayer AICNow+ for Total Glycated Hemoglobin 03/31/ QW *+ 14 Bayer DCA 2000 for glycosylated Hemoglobin (Hgb 11/12/ QW A 1c ) *+ 14 Bayer DCA for Glycosylated Hemoglobin (Hgb 10/30/ QW A 1c ) *+ 14 Bio-Rad Micromat II Hemoglobin A1c Prescription 12/17/ QW Home use test *+ 14 Bristol Myers Squibb Co. Choice DM for glycosylated 8/26/ QW hemoglobin total *+ 14 Cholestech GDX A 1c Test (Prescription Home Use) for 07/01/02 HbA 1c *+ 14 MEC Dynamics Avie A1c Test System for Hgb A1c 04/01/ QW *+ 14 Metrika A1 c Now for Home Use 11/19/ QW *+ 14 Metrika A1Cnow for Home Use for Hbg A1c 12/23/ QW *+ 14 Metrika DRx R HbA 1c & Metrika A1 c Now (Professional 11/27/ QW & Prescription Home Use) 08/17/01 03/08/02 *+ 14 Metrika DXR Professional Use Hemoglobin A1C Test 12/23/ QW *+ 14 Metrike Inview Multi-Test A1C Monitor (for OTC use 6/15/ QW & for Professional use) *+ 14 Provalis Diagnostics Glycosal TM HBA1c test 11/9/ QW *+ 14 Provalis Diagnostics In2it In-Office Analyzer (I&II) 11/9/ QW A1C for Hgb A1C *+ 14 Siemans Medical Diagnostics DCA Vantage Analyzer 10/11/ QW for glycosylated hemoglobin (Hgb A1 c *+ 14 Wako APOLOWAKO Analyzer for (Whole Blood) for 10/31/ QW Hgb A1c * Step Detect Associates DTX Drug Test Cup 04/30/ QW Integrated E-Z-Split Key Cup II for amphetamines, Cannabinoids, Cocaine metabolites, methamphetamine/amphetamine, MDMD, phencyclidine and opiates. *+ 15 Abbott Diagnostics Signify ER Drug Screen Test for 01/08/ QW Amphetamines, Barbiturates, Benzodiazepines, Cocaine Metabolites, Cannabinoids (THC), Methylenedioxymethamphetamine (MDMA), Opiates, Oxycodone, Phencyclidine (PCP), Propoxyphene, Propoxyphene and Tricyclic Antidepressants *+ 15 Accu-Stat Drugs of Abuse Home Test Cup for 8/24/ QW Marijuana *+ 15 Accu-Stat Drugs of Abuse Home Test Cup for 8/24/ QW 15

16 Marijuana and Cocaine *+ 15 Accu-Stat Drugs of abuse Home Test Cup for 8/19/ QW Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates and Phencyclidine *+ 15 Accu-Stat Drugs of Abuse Home Test for Marijuana, 2/17/ QW Cocaine, Amphetamine, Methamphetamine, Opiates and Phenycyclidine *+ 15 Accu-Stat Home Drug Test cup for Marijuana, cocaine, 05/26/ QW Amphetamine, Methamphetamine, Opiates and Phencyclidine *+ 15 Accutest Multi-Drug, Multi-Line Screen Device for 9/1/ QW amphetamines, cocaine, cannabinoids, methamphetamines, opiates and phenycyclidine. *+ 15 ACON Laboratories On Call Multi-Drug Home Test for 3/16/ QW amphetamines, cannabinoids, cocaine, methamphetamines, opiates and phencyclidine. *+ 15 Acon Laboratories Tri-Fect & Multi-Clin Drug Screen 05/01/ QW Test Device for Barbiturates, Amphetamines, Benzodiazepines, Cocaine, MDMA, Morphine, Oxycodone, PCP, Propoxyphene, Tricyclic Antidepressants & THC *+ 15 ACON Laboratories, On Call Multi-Drug Home Test 6/10/ QW Cup for amphetamines, cannabinoids, cocaine, methamphetamines, opiates and phencyclidine. *+ 15 Acon Multi-Drug Multi-Line Screen Test Card with 9/13/ QW Integrated Cup {Professional Use} for amphetamines, cocaine, cannabinoids, methamphetamines, MDMA, opiates and phenycyclidine. *+ 15 ACON One Step Multi-Line Device (Professional Use) 6/3/ QW for amphetamines, cannabinoids, cocaine, methamphetamines, opiates and phencyclidine. *+ 15 ADA CLIA Waived Marijuana (THC) & Cocaine Test 4/30/ QW *+ 15 ADA CLIA Waived Marijuana (THC) Test 4/29/ QW *+ 15 ADA CLIA waived Multiple Drug Test Card for 5/3/ QW opiates, methamphetamines, cocaine, THC and PCP *+ 15 Advantage Diagnostics Advantage Marijuana (THC) & 08/22/ QW Cocaine Home Drug Test. *+ 15 Advantage Diagnostics Advantage Multiple Drugs of 12/09/ QW abuse (MOA) Test for opiates, methamphetamines, cocaine (THC) and PCP Professional use test system *+ 15 Advantage Diagnostics Advantage THC Test 12/09/ QW Professional use test system *+ 15 Advantage Diagnostics Corporation ADC Multiple 2/24/ QW Drug Test Card for Cocaine, THC, methamphetamines, opiates and PCP. *+ 15 Alatex Scientific Marijuana (THC) Home Drug Test 3/17/ QW *+ 15 Alatex Scientific Peace of Mind Marijuana (THC) and 03/17/ QW 16

17 Cocaine Home Drug Test *+ 15 Alatex Scientific Peace of Mind Multiple Drugs of 2/21/ QW Abuse Test for cannabinoids (THC), cocaine metabolites, methamphetamines, morphine and phencyclidine (PCP) *+ 15 Amedica Biotech The Amedica Home Drug Test Cup & 01/05/ QW AmediCheck Instant Test Cup for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (THC), Cocaine Metabolites, Methadone, Methamphetamines, Methylenedioxymethamphetamine (MDMA), Opiates, Oxycodone, Phencyclidine (PCP), Tricyclic Antidepressants, 09/08/10 *+ 15 American Bio Medica Rapid TOX for Amphetamines, 08/18/ QW Barbiturates, Benzodiazepines, Buprenorphine, Cocaine Metabolites, MDMA, Methadone, Methamphetamines, Opiates, Oxycodone, PCP, Propoxyphene, Cannabinoids, Tricyclic Antidepressants *+ 15 American Screening Corporation One Screen Drug Test 12/03/ QW cards for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (TSH), Cocaine Metabolites, Methadone, MDMA, Morphine, Opiates, Oxycodone, Phenecyclidine, Tricyclic Antidepressants, Methamphetamines *+ 15 American Screening Corporation One Screen Drug Test 12/03/ QW Cups for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (TSH), Cocaine Metabolites, Methadone, MDMA, Morphine, Opiates, Oxycodone, Phenecyclidine, Tricyclic Antidepressants, Methamphetamines *+ 15 Applied Biotech Cocaine test 02/04/ QW *+ 15 Applied Biotech THC Test 02/04/ QW *+ 15 Biotechnostix Rapid Response Multi-Drug, Multi-Line 02/27/ QW Screen Test Card with Integrated Cup for amphetamines, COC, THC, MET, MDMA, OPI & PCP *+ 15 Biotechnostix, Inc. Rapid Response One Step Multi- 03/03/ QW Drug, Multi-Line Screen Test Device for amphetamines, cannabinoids, cocaine, methamphetamines, opiates and PCP *+ 15 Branan Medical Corporation Fastect II Drug Screen 1/26/ QW Dipstick Test for cannabinoids, amphetamines, cocaine metabolites, opiates, methamphetamines, methylenedioxymethamphetamine, barbiturates, benzodiazepines, methadone, oxycodone, phencyclidine, and tricyclic antidepressants *+ 15 Branan Medical Corporation ToxCup Drug Screen Cup for amphetamines, barbiturates, benzodiazeprines, cannabinoids, cocaine metabolites, methadone, methamphetamines, MDMA, opiates, oxycodone and 7/19/ QW 17

18 phencyclidine *+ 15 Branan Medical Corporation, Quick ToxDrug Screen Dipcard for amphetamines, barbiturates, benzodiazeprine, THC, Cocaine, Methadone, methamphetamines, MDMA, Opiates, Oxycodone, PCP and tricyclic antidepressants. *+ 15 BTNX Inc Rapid Response & Know Multi-Drug One Step Screen Test Panel for Amphetamines, Barbiturates, Benzodiazepines, Cocaine Metabolites, Methamphetamines, Morphine, PCP, Tricyclic Antidepressants, Cannabinoids, MDMA, Methadone *+ 15 CLIA waived, Inc. Rapid Drug Test Cup {OTC}for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (THC), Cocaine Metabolites, Methadone, Methamphetamines, MDMA, Opiates, Oxycodone, Phencyclidine (PCP), Tricyclic Antidepressants *+ 15 CLIA Waived.com CLIA-X Multiple Drug Cup Test {Professional Version} for Cannabinoids (THC), Tricyclic Antidepressants, Phencyclidine (PCP), Oxycodone, Morphine, Methamphetamines, Methadone, Cocaine Metabolites, Benzodiazepines, Amphetamines, Barbiturates *+ 15 Diagnostic Test Group LLC Clarity Multi-Drug of Abuse Urine Test for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (THC), Cocaine Metabolites, Methadone, Methamphetamines, MDMA, Morphine, Phencyclidine (PCP), Tricyclic Antidepressants *+ 15 Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test with the Integrated Screeners AutoSplitKO Test Cup for cocaine, cannabinoids, methamphetamines, MDMA, opiates, PCP and amphetamines *+ 15 DynaGen NicCheck I Test Strips (Nicotine and/or its metabolites) *+ 15 escreen, Inc. mcheck Multi-Line Screen Test Device for the analytes amphetamines, cannabinoids, cocaine metabolites, methamphetamines, opiates and PCP *+ 15 Express Diagnostics International Inc. DrugCheck Waive Multi Drug Screen Cups for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (THC), Cocaine Metabolites, Methadone, Methamphetamines, MDMA, Morphine, Opiates, Oxycodone, Phencyclidine (PCP), Tricyclic Antidepressants *+ 15 Express Diagnostics, DRUGCHECK Waive Cup for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (THC), Cocaine Metabolites, Methadone, Methamphetamines, MDMA, Opiates, Morphine, 11/14/ QW 01/08/ QW 04/21/ QW 01/07/ QW 05/3/ QW 12/28/ QW 8/26/ QW 06/28/ QW 4/30/ QW 4/21/ QW 18

19 Oxycodone, Phencyclidine (PCP), Tricyclic Antidepressants *+ 15 First Check Diagnostics First Check 12 Drug Test & First Check Multi Drug Cup 12 {OTC} for THC, COC, OPI, MET, amphetamines, PCP, benzodiazeprnes, barbiturates, methadone, tricyclic antidepressants, MDMA and oxycodone *+ 15 First Check Diagnostics First Check Multi Drug Cup for amphetamines, THC, COC, MDMA, MET, OPI & PCP *+ 15 First Check Diagnostics LLC, First Check Home Drug Test Marijuana for THC *+ 15 ForeFront Diagnostics TBC/COC Test Kit *+ 15 Forefront Diagnostics Instacheck Drug Screen for (THC) professional use test system *+ 15 Forefront Diagnostics Instacheck Multi-Drug Screen Panel (THC/COC) *+ 15 Icasstette Multi-Drug, Multi-Line Screen Test Device for amphetamines, cocaine, cannabinoids, methamphetamines, opiates and phenycyclidine. *+ 15 Innovacon Integrated E-Z Split Key Cup II & E-Z Split Cup II{Professional Use} for Cocaine, THC, methamphetamines, MDMA, Opiates, PCP and amphetamines *+ 15 Innovacon Multi-Clin Drug Screen Test Device & Jant Pharmacal Accutest MultiDrug ER 11 Drug screen test device for the analytes amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, MDMA, opiates, oxycodone, PCP, propoxyphene and tricyclic antidepressants. *+ 15 Instant Technologies OTC icassette Home Drug test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates and PCP *+ 15 Instant Technologies OTC icup Home Drug test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates and PCP *+ 15 Instant Technologies OTC Inc. itest for Drugs of Abuse, icassette Home Drug Test for Marijuana and Cocaine *+ 15 Instant Technologies OTC Inc. itest for Drugs of Abuse, icassette Home Test for Marijuana *+ 15 Instant Technologies, icup Dx Drug Screen Cup for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (THC), Cocaine Metabolites, Methadone, Methamphetamines, MDMA, Morphine, Opiates, Oxycodone, Phencyclidine (PCP), Tricyclic 02/22/ QW 01/17/ QW 05/01/ QW 7/27/01 01/23/ QW 0123/ QW 7/8/ QW 02/22/ QW 05/24/ QW 06/15/ QW 06/15/ QW 08/08/ QW 08/08/ QW 6/3/ QW 19

20 Antidepressants *+ 15 Instant Technologies, Inc. iscreen Multi-Drug of Abuse Urine Test for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (THC), Cocaine Metabolites, Methadone, Methamphetamines, MDMA, Morphine, Phencyclidine (PCP), Tricyclic Antidepressants *+ 15 Inverness Medical Innovations Signify ER Drug Screen for Amphetamines, Barbiturates, Benzodiazepines, Cocaine Metabolites, Cannabinoids, Methylenedioxymethamphetamine (MDMA), Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressants *+ 15 Jant Pharmacal Accutest SplitCup for analytes amphetamines, cannabinoids, cocaine metabolites, methamphetamines, MDMA, opiates and PCP *+ 15 Jant Pharmacal Corporation Accutest Multi-Drug of Abuse Urine Test for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (THC), Cocaine Metabolites, Methadone, Methamphetamines, MDMA, Phencyclidine (PCP), Tricyclic Antidepressants *+ 15 MedDirect, Inc Multiple Drug Screen Cups for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (THC), Cocaine Metabolites, Methadone, Methamphetamines, MDMA, Morphine, Opiates, Oxycodone, Phencyclidine (PCP), Tricyclic Antidepressants *+ 15 MedDirect, Inc ProXam Drug Test Cards for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (THC), Cocaine Metabolites, Methadone, Methamphetamines, MDMA, Morphine, Opiates, Oxycodone, Phencyclidine (PCP), Tricyclic Antidepressants *+ 15 Millennium Laboratories Clinical Supply, Inc Multi- Drug Pain Med Screen Cup for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (THC), Cocaine Metabolites, Methadone, Methamphetamines, MDMA, Opiates, Oxycodone, Phencyclidine (PCP), Tricyclic Antidepressants *+ 15 Mossman Assoc, Inc NicCheck I Test Strips for Nicotine And/Or Metabolites *+ 15 Noble Medical Inc. NOBLE 1 Step Cup {OTC} for Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids (THC), Cocaine Metabolites, Methadone, Methamphetamines, MDMA, Opiates, Oxycodone, Phencyclidine (PCP), Tricyclic Antidepressants *+ 15 Noble Medical Inc. Split-Specimen Cup for Amphetamines, Cocaine, THC, Methamphetamines, 05/3/ QW 08/24/ QW 08/07/ QW 05/3/ QW 6/3/ QW 6/3/ QW 4/21/ QW 11/04/ QW 4/21/ QW 04/19/ QW 20

21 MDMA, Opiates & PCP *+ 15 OraSure Technologies Q.E.D. A-150 Saliva Alcohol Test and A-350 Saliva Alcohol Tests *+ 15 Phamatech At Home 12 Drug Test for Model 9308Z & 9308T for Amphetamines, Cannabinoids (THC), Cocaine Metabolites, Phencyclidine, Barbiturates, Methadone, Oxycodone, Opiates, Methamphetamines, MDMA, Benzodiazepines *+ 15 Phamatech At Home Drug Cocaine & THC Screening Test (Model 9170) *+ 15 Phamatech At Home Drug Test (Model 9063) for amphetamine & Model 9063T & Model 9064 & Model 9150X *+ 15 Phamatech At Home Drug Test (Model 9068) for methamphetamines & Model 9068T & Model 9069 & Model 9150X *+ 15 Phamatech At Home Drug Test (Model 9073) for cocaine metabolites & Model 9073T & Model 9074 & Model 9150X *+ 15 Phamatech At Home Drug Test (Model 9078) for cannabinoids & Model 9078T & Model 9079 & Model 9150X *+ 15 Phamatech At Home Drug Test (Model 9083) for opiates & Model 9083T & Model 9084 X Model 9150X *+ 15 Phamatech At Home Drug Test (Model 9133) for phencycoidine (PCP) & Model 9133T *+ 15 Phamatech at Home Drug Test (Model 9150) for cannabinoids, opiates, cocaine metabolites, methamphetamine, amphetamine & Model 9150T *+ 15 Phamatech At Home Drug Test (Model 9175) for methamphetamines, cannabinoids and opiates *+ 15 Phamatech Quickscreen (Model 9177X) and (Model 9178X) for Amphetaminess, Cocaine, Opiates, PCP, THC & Methamphetamine *+ 15 Phamatech QuickScreen At Home Drug Test (Model 9171) for methamphetamines and opiates *+ 15 Phamatech QuickScreen At Home Drug Test for Amphetamines, cocaine metabolites, methamphetamines, opiates, PCP and cannabinoids. *+ 15 Phamatech QuickScreen One Step Amphetamine Test (Professional use) 1/22/ QW 01/08/ QW 4/19/ QW 4/19/00 4/24/01 12/17/01 4/29/03 4/19/00 7/20/01 12/17/01 4/29/03 4/19/00 4/24/01 12/17/01 4/29/03 4/19/00 4/27/01 12/17/01 4/29/03 4/19/00 4/24/01 12/17/01 4/29/03 4/19/00 4/24/01 2/27/01 7/20/ QW 80101QW 80101QW 80101QW 80101QW 80101QW 80101QW 4/19/ QW 2/15/ QW 4/19/ QW 4/19/ QW 08/23/ QW 21

22 *+ 15 Phamatech QuickScreen One Step Cocaine Screening 08/23/ QW Test (Professional use) *+ 15 Phamatech QuickScreen One Step Methamphetamine 08/23/ QW Test ( Professional use) *+ 15 Phamatech QuickScreen One Step Opiate Screen Test 08/23/ QW (Professional use) *+ 15 Phamatech QuickScreen one Step Phencyclidine (PCP) 08/23/ QW Screening Test (Professional Use) *+ 15 Phamatech QuickScreen Pro Multi Drug Screening Test 08/29/ QW (Model 9177 and 9178) for Methamphetamine, Cannabinoids (THC), PCP, Amphetamine, Cocaine and Opiates (Professional use) *+ 15 Princeton Biomeditech Accusign COC 06/05/ QW *+ 15 Princeton Biomeditech Accusign DOA 4 06/07/ QW (THC/OPI/COC/MET) *+ 15 Princeton Biomeditech Accusign Stik 06/07/ QW (THC/OPI/COC/MET) *+ 15 Princeton Biomeditech Accusign Stik COC 06/05/ QW *+ 15 Princeton Biomeditech Accusign Stik Met 06/07/ QW *+ 15 Princeton Biomeditech Accusign Stik THC 06/07/ QW *+ 15 Princeton Biomeditech Accusign THC 06/07/ QW *+ 15 Princeton Biomeditech Accustik COC 06/05/ QW *+ 15 Princeton Biomeditech Accustik DOA 4 06/07/ QW *+ 15 Princeton Biomeditech Accustik Met 06/07/ QW *+ 15 Princeton Biomeditech Accustik THC 06/07/ QW *+ 15 Princeton Biomeditech Accustrip COC 06/05/ QW *+ 15 Princeton Biomeditech Accustrip DOA 4 06/07/ QW (THC/OPI/COC/MET) *+ 15 Princeton Biomeditech Accustrip Met 06/07/ QW *+ 15 Princeton Biomeditech Accustrip THC 06/07/ QW *+ 15 Princeton Biomeditech Lifesign Home Drug Test 06/07/ QW (THC/OPI/COC/MET) *+ 15 Princeton Biomeditech Lifesign Home Drug Test 06/05/ QW Cocaine *+ 15 Princeton Biomeditech Lifesign Home Drug Test 06/07/ QW Marijuana *+ 15 Princeton Biomeditech Lifesign Home Drug Test Met 06/07/ QW *+ 15 Princeton Biomeditech Status DS COC 09/05/ QW *+ 15 Princeton Biomeditech Status DS DOA 4 06/07/ QW (THC/OPI/COC/MET) *+ 15 Princeton Biomeditech Status DS Met 06/07/ QW *+ 15 Princeton Biomeditech Status DS THC 06/07/ QW *+ 15 Princeton Biomeditech Status Stik 06/07/ QW (THC/OPI/COC/MET) *+ 15 Princeton Biomeditech Status Stik COC 09/05/ QW *+ 15 Princeton Biomeditech Status Stik Met 06/07/ QW *+ 15 Princeton Biomeditech Status Stik THC 06/07/ QW 22