EU Declaration of Conformity

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1 EU Declaration of Conformity Omega Diagnostics Omega House Hillfoots Business Village Alva Scotland United Kingdom FK12 5DQ Manufacturer Identification Code GB / Medicines and Healthcare Products Regulatory Agency Competent Authority GB / CA 01 Herewith declare that the attached listed products meet the applicable provisions of the EU Directive 98 / 79 / EEC on in vitro diagnostic medical devices for IVD s which are not Annex II or self-testing devices by self conformity assessment and carry the CE mark accordingly. Alva, 28th January 2008 Norman Hawkes Technical Manager

2 Page 1 of 19 Immunochemistry ( 12 ) Allergy ( ) Immuglobulin E- Total PATHOZYME IgE OD Tests Tumor Markers ( ) Cancer Antigens ( ) Cancer Antigen 15-3 PATHOZYME BREAST CANCER Ag 15-3 OD Tests Cancer Antigen 19-9 PATHOZYME Ag19-9 OD Tests Cancer Antigen 125 PATHOZYME Ag 125 OD Tests Carcinoembryonic Antigen PATHOZYME CEA (CARCINOEMBRYONIC Ag) OD Tests Alphafetoprotein PATHOZYME AFP OD Tests

3 Page 2 of 19 Thyroid Function Hormones ( ) Thyroid Function Hormones ( ) Free Triidothyronine PATHOZYME FREE T3(TRIIODOTHYRONINE) OD Tests Free Thyroxine PATHOZYME FREE T4 (THYROXINE) OD Tests Triidothyronine PATHOZYME T3 (TRIIODOTHYRONINE) OD Tests Thyroxine PATHOZYME T4 (THYROXINE) OD Tests Thyroid Stimulating Hormone PATHOZYME TSH OD Tests PATHOZYME USTSH OD Tests

4 Page 3 of 19 Fertility Function Hormones / Proteins ( ) Fertility Function Hormones / Proteins ( ) Estradiol ( E2 ) PATHOZYME OESTRADIOL OD Tests Follicle Stimulating Hormone ( FSH ) PATHOZYME FSH (FOLLICLE STIM. HORMONE) OD Tests Luteinising Hormone ( LH ) PATHOZYME LH OD Tests Progesterone ( PRG ) PATHOZYME PROGESTERONE OD Tests Prolactin ( PRL ) PATHOZYME PROLACTIN OD Tests Testosterone PATHOZYME TESTOSTERONE OD Tests

5 Page 4 of 19 Pregnancy Testing Hormones / Proteins ( ) Human Chorionic Gonadotropin Total ( hcg ) BETATEX DIRECT PLUS OD Tests OD Tests PATHOZYME hcg OD Tests

6 Page 5 of 19 Individual Specified Hormones ( ) Endocrine Hormones and Peptides ( ) Human Growth Hormone PATHOZYME HGH OD Tests Anemia Related / Vitamin Tests ( ) Anemia ( ) Ferritin PATHOZYME FERRITIN OD Tests

7 Page 6 of 19 Auto-Immune Disease Markers ( ) Autoimmune Connective Tissue Disease ( ) dsdna Antibodies AVITEX SLE OD Tests OD Tests OD173/A 25 Tests

8 Page 7 of 19 Rheumatoid Inflammatory Disease Markers ( ) Rheumatoid Inflammatory Disease Markers ( ) Anti-Streptolysin O ( ASO ) AVITEX ASO OD Tests OD033/E Tests ( Latex only ) OD Tests OD153/A 25 Tests C-Reactive Protein ( CRP ) AVITEX CRP OD Tests OD023/E Tests ( Latex only ) OD Tests OD143/A 25 Tests Rheumatoid Factors ( RF ) AVITEX RF OD Tests OD013/E -100 Tests ( Latex only ) OD Tests OD133/A 25 Tests AVITEX ROSE WAALER OD Tests

9 Page 8 of 19 Rapid Tests Immunochemistry ( ) Fertility / Pregnancy Rapid Tests ( ) hcg - Rapid Test VISITECT PREGNANCY OD Tests OD Tests

10 Page 9 of 19 Microbiology ( 14 ) Bacteriology - Identification & Susceptbility Testing ( ) Immunological Identification ( ) Streptococci AVIPATH STREP OD014/A - 50 Tests ( Latex A only ) OD014/B - 50 Tests ( Latex B only ) OD014/C - 50 Tests ( Latex C only ) OD014/D - 50 Tests ( Latex D only ) OD014/F - 50 Tests ( Latex F only ) OD014/G - 50 Tests ( Latex G only ) OD Tests Staphylococci AVIPATH STAPH OD Tests

11 Page 10 of 19 Parasitology ( ) Serological Detection and Identification ( Parasitology ) ( ) Plasmodium falciparum VISITECT MALARIA Pf OD Tests OD Test VISITECT MALARIA COMBO PAN Pf OD Tests

12 Page 11 of 19 Infectious Immunology ( 15 ) Bacteriology ( Infectious Immunology ) ( ) Syphilis ( Treponema pallidum ) ( ) Syphilis Antibody Assays Total IMMUTREP CARBON ANTIGEN OD031 5ml OD ml IMMUTREP RPR OD Tests OD Tests OD Tests IMMUTREP TPHA OD Tests OD Tests OD Tests OD071/A 200 Tests ( with Plates ) OD081/B 100 Tests ( with Plates ) OD211/C 1000 Tests ( with Plates )

13 Page 12 of 19 Syphilis ( Treponema pallidum ) ( ) Continued IMMUTREP USR OD ml OD111/A 10 ml ( with Positive Control ) IMMUTREP VDRL ANTIGEN ODO11 / 5ml PATHOZYME SYPHILIS COMPETITION OD Tests OD Tests Syphilis Antibody IgM PATHOZYME SYPHILIS M CAPTURE OD Tests

14 Page 13 of 19 Mycobacteria genus + species ( ) Mycobacterial Antibody Assays PATHOZYME MYCO IgA OD Tests PATHOZYME MYCO IgG OD Tests PATHOZYME MYCO IgM OD PATHOZYME TB COMPLEX PLUS OD Tests

15 Page 14 of 19 Salmonella ( ) Salmonella Antibody Assays MICROPATH SAL H-A OD Tests MICROPATH SAL H-B OD Tests MICROPATH SAL H-C OD Tests MICROPATH SAL H-D OD Tests MICROPATH SAL O-A OD Tests MICROPATH SAL O-B OD Tests MICROPATH SAL O-C OD Tests MICROPATH SAL O-D OD Tests

16 Page 15 of 19 Salmonella ( ) Continued MICROPATH FEBRILE ANTIGEN KITS OD225 4 X 100 Tests OD165 6 X 100 Tests OD155 8 X 100 Tests OD X 100 Tests

17 Page 16 of 19 Other Bacterial Immunoassays ( ) Brucella MICROPATH BRUCELLA ABORTUS OD Tests MICROPATH BRUCELLA MELITENSIS OD Tests ROSE BENGAL OD Tests Leptospira VISITECT LEPTO OD Tests Proteus MICROPATH PROTEUS OX19 OD Tests MICROPATH PROTEUS OX2 OD Tests MICROPATH PROTEUS OXK OD Tests

18 Page 17 of 19 Herpes Simplex Virus ( ) HSV 2 IgG PATHOZYME HSV-2 VIRO IgG OD Tests

19 Page 18 of 19 Epstein Barr Virus ( ) Other EBV Reagents AVITEX IM OD Tests OD Tests OD163/A 25 Tests Other Virology Antigen / Antibody Detection ( ) Rotavirus VIROTECT ROTA OD Tests Dengue Virus PATHOZYME DENGUE IgG OD Tests PATHOZYME DENGUE IgM OD Tests VISITECT DENGUE OD Tests

20 Page 19 of 19 Miscellaneous Parasitology ( Antibodies ) ( ) Chagas PATHOZYME T CRUZI OD Tests OD Tests Rapid Tests Infectious Immunology ( ) Bacteriology Rapid Tests ( ) Syphilis - Rapid Test VISITECT SYPH OD Tests Other Bacteriology Rapid Tests VISITECT TB OD Tests

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