Annex to the Accreditation Certificate D-ML according to DIN EN ISO 15189:2014
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1 Deutsche Akkreditierungsstelle GmbH German Accreditation Body Annex to the Accreditation Certificate D-ML according to DIN EN ISO 15189:2014 Period of validity: to Date of issue: Holder of certificate: Freiburg Medical Laboratory, Middle East LLC Trade Center Road P.O. Box 3068, Dubai UAE UNITED ARAB EMIRATES Tests in the fields: Medical Laboratory Diagnosis Analytical Field: Clinical Chemistry Immunology Microbiology Virology Type of Tests: Agglutination Chromatography (High Pressure Liquid Chromatography (HPLC)) Electrochemical Tests Flowcytometry Ligand Assays Microscopy Molecular Biological Methods (Amplification Method) Spectrometry (Photometry, Turbidimetry) The laboratory is permitted within the specified areas marked with* the free choice of standard or equivalent test methods, without being required to inform and obtain prior approval from DAkkS. The listed test methods are exemplary. The laboratory maintains a current list of all test methods in a flexible scope of accreditation. 1/9
2 Analytical field: Clinical Chemistry Type of test: Agglutination* ABO/Rh Blood Group + Reverse Grouping EDTA Blood, Serum Agglutination Rh Subgroups and Kell EDTA Blood Agglutination Coombs Test, direct EDTA Blood Agglutination Coombs Test, indirect Serum Agglutination Type of Test: Chromatography (High Pressure Liquid Chromatography (HPLC)) HbF EDTA Blood HPLC HbA 1 EDTA Blood HPLC HbA 2 EDTA Blood HPLC HbD EDTA Blood HPLC HbS EDTA Blood HPLC HbC EDTA Blood HPLC Type of test: Electrochemical tests* Chloride Serum, Heparin Plasma ISE Potassium Serum, Heparin Plasma ISE Sodium Serum, Heparin Plasma ISE Type of Test: Flowcytometry* Differential Blood Count EDTA Blood Flowcytometry White Blood Cell Count EDTA Blood Flowcytometry Hematocrit EDTA Blood RBC pulse height detection Hemoglobin EDTA Blood SLS-Hemoglobin Red Blood Cells EDTA Blood Hydro Dynamic Focussing Platelets EDTA Blood Hydro Dynamic Focussing RBC Index MCH EDTA Blood Calculation RBC Index MCV EDTA Blood Calculation RBC Index MCHC EDTA Blood Calculation Period of validity: to Date of issue: /9
3 Type of Test: Optical Clot Detection* aptt Citrated Plasma Optical Clot Detection PT Citrated Plasma Optical Clot Detection Lupus Anticoagulants Citrated Plasma Optical Clot Detection Fibrinogen Citrated Plasma Optical Clot Detection D-Dimer Citrated Plasma Optical Clot Detection INR Citrated Plasma Calculation Type of test: Microscopy Differential Blood Count (manual) EDTA Blood, Smear Microscopy Type of Test: Spectrometry (Photometry)* Albumin Serum, Heparin Plasma, EDTA Plasma Photometry Ammonia EDTA Plasma Photometry Bilirubin direct Serum, Heparin Plasma Photometry Bilirubin total Serum, Heparin Plasma, EDTA Plasma Photometry BUN/Urea Serum, Heparin Plasma, EDTA Plasma, Photometry Calcium Serum, Heparin Plasma Photometry Cholesterol Serum, Heparin Plasma, EDTA Plasma Photometry Creatinine Glucose Serum, Heparin Plasma, EDTA Plasma, Urine NaF Plasma, Serum, Heparin Plasma, EDTA Plasma, CSF Photometry Photometry Alkaline Phosphatase Serum, Heparin Plasma Photometry ALT Serum, Heparin Plasma, EDTA Plasma Photometry Amylase Serum, Heparin Plasma, Photometry Pancreatic Amylase Serum, Heparin Plasma Photometry AST Serum, Heparin Plasma, EDTA Plasma Photometry Cholinesterase Serum, Heparin Plasma, EDTA Plasma Photometry CK Serum, Heparin Plasma, EDTA Plasma Photometry GGT Serum, Heparin Plasma, EDTA Plasma Photometry LDH Serum, Heparin Plasma, EDTA Plasma Photometry Lipase Serum, Heparin Plasma Photometry HDL-Cholesterol Serum, Heparin Plasma, EDTA Plasma Photometry Period of validity: to Date of issue: /9
4 Iron Serum, Heparin Plasma Photometry Lactate NaF Plasma, CSF Photometry LDL-Cholesterol Serum, Heparin Plasma Photometry Magnesium Serum, Heparin Plasma Photometry Phosphorus Serum, Heparin Plasma, EDTA Plasma Photometry Protein Serum, Heparin Plasma, EDTA Plasma Photometry Protein, Urine + CSF Urine, CSF Photometry Triglycerides Serum, Heparin Plasma, EDTA Plasma Photometry UIBC Serum, Heparin Plasma Photometry Uric acid Serum, Heparin Plasma, EDTA Plasma Photometry Ethanol Serum, EDTA Plasma Photometry Homocysteine EDTA plasma, Heparin Plasma, Serum Photometry Carbamazepine Serum, Heparin Plasma Photometry Valproic Acid Serum, Heparin Plasma Photometry LDL Friedewald Serum, Heparin Plasma Calculation Type of Test: Spectrometry (Turbidimetry)* Albumin Urine / CSF Urine, CSF Turbidimetry Apolipoprotein A1 Serum, Heparin Plasma, EDTA Plasma Turbidimetry Antistreptolysin O Serum, Heparin Plasma, EDTA Plasma Turbidimetry Complement C3c Serum, Heparin Plasma Turbidimetry Complement C4 Serum, Heparin Plasma, EDTA Plasma Turbidimetry CRP Serum, Heparin Plasma, EDTA Plasma Turbidimetry Ferritin Serum, Heparin Plasma, EDTA Plasma Turbidimetry Haptoglobin Serum, Heparin Plasma, EDTA Plasma Turbidimetry Immunoglobulin A Serum, Heparin Plasma, EDTA Plasma Turbidimetry Immunoglobulin G Serum, Heparin Plasma, EDTA Plasma Turbidimetry Immunoglobulin M Serum, Heparin Plasma, EDTA Plasma Turbidimetry Lipoprotein (a) Serum, Heparin Plasma, EDTA Plasma Turbidimetry Rheumatoid Factor Serum, Heparin Plasma, EDTA Plasma Turbidimetry HBA1c IFCC EDTA Blood Turbidimetry HBA1c DCCT EDTA Blood Turbidimetry Cystatin C Serum Turbidimetry Period of validity: to Date of issue: /9
5 Glomerular Filtration Rate/GFR Serum Calculation Estimated Average Glucose EDTA Blood Calculation Albumin/Creatinine Ratio Urine Calculation Total Protein/Creatinine Ratio Urine Calculation Analytical field: Immunology Type of test: ligand-assays** Electrochemiluminescence immunoassay AFP Serum, Heparin Plasma, EDTA Plasma ECLIA CA 15-3 Serum, Heparin Plasma, EDTA Plasma ECLIA CA 19-9 Serum, Heparin Plasma, EDTA Plasma ECLIA CA 125 Serum, Heparin Plasma, EDTA Plasma ECLIA CEA Serum, Heparin Plasma, EDTA Plasma ECLIA Total PSA Serum, Heparin Plasma, EDTA Plasma ECLIA Free PSA Serum, Heparin Plasma, EDTA Plasma ECLIA Free PSA % Serum Calculation Thyreoglobulin (TG) Serum, Heparin Plasma, EDTA Plasma ECLIA Cortisol Serum, Heparin Plasma, EDTA Plasma ECLIA DHEA-S Serum, Heparin Plasma, EDTA Plasma ECLIA Estradiol Serum, Heparin Plasma, EDTA Plasma ECLIA FSH Serum, Heparin Plasma, EDTA Plasma ECLIA HCG+Beta Serum, Heparin Plasma, EDTA Plasma ECLIA Insulin Serum, Heparin Plasma, EDTA Plasma ECLIA LH Serum, Heparin Plasma, EDTA Plasma ECLIA Progesterone Serum, Heparin Plasma, EDTA Plasma ECLIA Prolactin Serum, Heparin Plasma, EDTA Plasma ECLIA SHBG Serum, Heparin Plasma, ECLIA Testosterone Serum, Heparin Plasma, EDTA Plasma ECLIA Folate Serum, Heparin Plasma ECLIA Period of validity: to Date of issue: /9
6 Vitamin B12 Serum, Heparin Plasma, EDTA Plasma ECLIA Vitamin D (25OH) Serum, Heparin Plasma, EDTA Plasma ECLIA Anti-TG Serum, EDTA Plasma ECLIA Anti-TPO Serum, Heparin Plasma, EDTA Plasma ECLIA CK-MB Serum, Heparin Plasma, EDTA Plasma ECLIA Troponin T, high sensitive Serum, Heparin Plasma, EDTA Plasma ECLIA PTH, intact EDTA Plasma, Serum ECLIA Free T3 Serum, Heparin Plasma, EDTA Plasma ECLIA Free T4 Serum, Heparin Plasma, EDTA Plasma ECLIA Total T3 Serum, Heparin Plasma, EDTA Plasma ECLIA Total T4 Serum, Heparin Plasma, EDTA Plasma ECLIA TSH Serum, Heparin Plasma, EDTA Plasma ECLIA IgE, total Serum, Heparin Plasma, EDTA Plasma ECLIA HCG+Beta, free Serum ECLIA PAPP-A Serum ECLIA Immunoblot Food Allergy Screening Serum Immunoblot Respiratory Allergy Screening Serum Immunoblot ANA Profile Serum Immunoblot Enzyme Immunoassay (EIA) dsdna/nucleosomes Abs Serum EIA CCP Abs Serum EIA Phospholipid IgG Serum EIA Phospholipid IgM Serum EIA Cardiolipin IgG Serum EIA Cardiolipin IgM Serum EIA Tissue Transglutaminase IgA Serum EIA Tissue Transglutaminase IgG Serum EIA Period of validity: to Date of issue: /9
7 Type of Test: Microscopy* ANA/ASMA type Actin Serum IFT ANCA (canca, panca) Serum IFT AMA/M2/LKM Serum IFT Endomysium IgA Serum IFT Gliadin IgA Serum IFT Analytical field: Microbiology Type of test: Agglutination TPHA Serum Agglutination Type of test: Ligand-assays* Electrochemiluminescenceimmunoassay Toxoplasma IgG Serum, Heparin Plasma, EDTA Plasma ECLIA Toxoplasma IgM Serum, Heparin Plasma, EDTA Plasma ECLIA Enzyme Immunoassay (EIA) Mycopl. Pneum. IgM Serum EIA Mycopl. Pneum. IgA Serum EIA Mycopl. Pneum. IgG Serum EIA Helicobacter Pylori Ag Stool Immunchromatography Type of Test: Molecular Biological Methods (Amplification Method) Chlamydia trachomatis DNA Swab, Urine PCR Period of validity: to Date of issue: /9
8 Analytical field: Virology Type of test: Ligand-Assays * Electrochemiluminescence immunoassay Anti-HBc Serum, Heparin Plasma, EDTA Plasma ECLIA Anti-HBe Serum, Heparin Plasma, EDTA Plasma ECLIA Anti-HBs Serum, EDTA Plasma ECLIA HbeAg Serum, Heparin Plasma, EDTA Plasma ECLIA HbsAg Serum, Heparin Plasma, EDTA Plasma ECLIA Anti-HAV Serum, Heparin Plasma, EDTA Plasma ECLIA Anti-HAV IgM Serum, Heparin Plasma, EDTA Plasma ECLIA HIV combi Serum, Heparin Plasma, EDTA Plasma ECLIA Rubella IgG Serum, Heparin Plasma, EDTA Plasma ECLIA Rubella IgM Serum, Heparin Plasma, EDTA Plasma ECLIA HCV Abs Serum, Heparin Plasma, EDTA Plasma ECLIA CMV Abs IgG Serum, Heparin Plasma, EDTA Plasma ECLIA CMV ABS IgM Serum, Heparin Plasma, EDTA Plasma ECLIA Enzyme Immunoassay (EIA) HSV 1 IgG Serum EIA HSV 1 IgM Serum EIA HSV 2 IgG Serum EIA HSV 2 IgM Serum EIA HSV 1/2 IgG Serum EIA HSV 1/2 IgM Serum EIA Immunoblot HCV Genotyping Amplicon Blot Period of validity: to Date of issue: /9
9 Type of Test: Microscopy* EBV-CA-IgG Serum IFT EBV-CA-IgM Serum IFT EBV-EA-IgG Serum IFT EBNA Serum IFT Type of Test: Molecular Biological Methods (Amplification Method)* HCV RNA EDTA Plasma, Serum PCR HBV DNA EDTA Plasma, Serum PCR Period of validity: to Date of issue: /9
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