EC Declaration of Conformity (Directive 98/79/EC)

Transcription

1 Page 1 of 20 EC Declaration of Conformity (Directive 98/79/EC) Manufacturer Omega Diagnostics Ltd., Omega House, Hillfoots Business Village, Alva, Scotland, United Kingdom FK12 5DQ Manufacturer Identification Code: GB / Competent Authority: Medicines and Healthcare Products Regulatory Agency, Competent Authority GB / CA 01 Product Details: Classification: See (attached) IVDD, Non Annex II, Self Declaration Conformity Assessment Route: Annex III IVDD We hereby declare the devices named in the (see attached) comply with the requirements of DIRECTIVE 98/79/EC, on in vitro diagnostic medical devices. Standards Applied: EN ISO 9001:2008, EN ISO 13485:2012, EN ISO 14971:2009, EN ISO :2009, EN ISO : 2012, EN 13612:2002, EN 13640:2002 and EN 13641:2002. Signed: Name: Norman Hawkes Position: Technical Manager Place: Omega Diagnostics, Omega House, Hillfoots Business Village, Alva, Scotland, United Kingdom, FK12 5DQ Date: 3 rd June 2013 ISSUE NO: 9 DATE: 3 June 2013 COMPILED BY: Norman Hawkes APPROVED BY: Andrew Shepherd

2 Page 2 of 20 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 3 of 20 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 4 of 20 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 5 of 20 Pregnancy Testing Hormones / Proteins ( ) Human Chorionic Gonadotropin Total ( hcg ) BETATEX DIRECT PLUS OD Tests OD Tests PATHOZYME hcg OD Tests

6 Page 6 of 20 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 7 of 20 Auto-Immune Disease Markers ( ) Autoimmune Connective Tissue Disease ( ) dsdna Antibodies AVITEX SLE OD Tests OD Tests OD173/A 25 Tests

8 Page 8 of 20 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 OD343 AVITEX TURBO ASO 50ml OD253 AVITEX TURBO RF/CRP/ASO Low Positive Control 4 x 1ml OD263 AVITEX TURBO RF/CRP/ASO High Positive Control 4 x1ml

9 Page 9 of 20 AVITEX CRP OD Tests OD023/E Tests ( Latex only ) OD Tests OD143/A 25 Tests C-Reactive Protein ( CRP ) OD363 AVITEX TURBO CRP 50ml OD253 AVITEX TURBO RF/CRP/ASO Low Positive Control 4 x 1ml OD263 AVITEX TURBO RF/CRP/ASO High Positive Control 4 x 1ml Rheumatoid Factors ( RF ) AVITEX RF OD Tests OD013/E -100 Tests ( Latex only ) OD Tests OD133/A 25 Tests OD353 AVITEX TURBO RF 50ml OD253 AVITEX TURBO RF/CRP/ASO Low Positive Control 4 X 1ml OD263 AVITEX TURBO RF/CRP/ASO High Positive Control 4 x 1ml AVITEX ROSE WAALER OD Tests

10 Page 10 of 20 Rapid Tests Immunochemistry ( ) Fertility / Pregnancy Rapid Tests ( ) hcg - Rapid Test VISITECT PREGNANCY OD Tests OD Tests

11 Page 11 of 20 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 ) OD014/L - 50 Tests Staphylococci AVIPATH STAPH OD Tests

12 Page 12 of 20 Parasitology ( ) Serological Detection and Identification ( Parasitology ) ( ) Plasmodium falciparum VISITECT MALARIA Pf OD Tests OD Test VISITECT MALARIA COMBO PAN Pf OD Tests

13 Page 13 of 20 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 OD051/T 100 Tests OD Tests IMMUTREP TPHA OD Tests OD Tests OD Tests OD Tests OD071/A 200 Tests ( with Plates ) OD081/B 100 Tests ( with Plates )

14 Page 14 of 20 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

15 Page 15 of 20 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

16 Page 16 of 20 Salmonella ( ) Salmonella Antibody Assays MICROPATH Ha OD Tests MICROPATH Hb OD Tests MICROPATH Hc OD Tests MICROPATH Hd OD Tests MICROPATH OA OD Tests MICROPATH OB OD Tests MICROPATH OC OD Tests MICROPATH OD OD Tests

17 Page 17 of 20 Salmonella ( ) Continued MICROPATH X 4 OD Tests MICROPATH X 6 OD Tests MICROPATH X 6 OD Tests MICROPATH X 8 OD Tests MICROPATH X 10 OD Tests

18 Page 18 of 20 Other Bacterial Immunoassays ( ) Brucella MICROPATH BRUCELLA ABORTUS OD Tests MICROPATH BRUCELLA MELITENSIS OD Tests MICROPATH 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

19 Page 19 of 20 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 CAPTURE OD Tests VISITECT DENGUE OD Tests

20 Page 20 of 20 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