DECLARATION OF CONFORMITY
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1 Page: 1 of 5 DECLARATION OF CONFORMITY 1) Manufacturer (Name, department): Calbiotech, Inc. Address: Austin Drive, SPRING VALLEY, CA 91978, USA. and 2) European authorized representative: CEpartner4U BV, Address: ESDOORNLAAN 13, 3951DB MAARN, THE NETHERLANDS; (on product labels printed as: CEpartner4U, ESDOORNLAAN 13, 3951DB MAARN, THE NETHERLANDS Tel.: +31 (0) ; or as: CEpartner4U, 3951DB; 13. NL tel: +31 (0) ) 3) Product(s) (name, type or model/batch number, etc.): - ELISA Test Kits - Chemiluminescence Test Kits (LumELISA) see appendix 4) The product(s) described above is in conformity with: Title Document No. Date of issue In vitro Diagnostic Medical Devices Directive 98/79/EC As amended (EC) No 1882/ ) The product(s) described in the attached appendix is in conformity to the current European IVDD Directive and the associated quality management system is in compliance to ISO 13485:2003 (Certificate # UQA ). 6) Additional information (conformity procedure, Notified Body, CE certificate, etc.): Conformity assessment procedure for CE marking: Medical Device Directive, Annex III Spring Valley, USA; Mr. David Barka, Director of Quality System and IVD compliance (Place & date of issue (yyyy-mm-dd)) (Name; function and signature of manufacturer) Maarn, NL; Rogier Nusselder; Consultant, CEpartner4U BV (Place & date of issue (yyyy-mm-dd)) (name; function and signature of authorized representative) vs Declaration form: Standard ISO/IEC :2004
2 Page: 2 of 5 Appendix Date: List of devices. Endocrine Markers ACTH AC018T ACTH ELISA AC018T Cortisol CO078S Cortisol Saliva CO116S Cortisol ELISA (Sheep) CO116S C-Peptide CP097D C-Reactive Protein CR-016C DHEA-S DH079S Estradiol ES071S Free Estriol EF068F Free Testosterone FT014S Free Thryoxine (FT4) FT Free Triiodothyronine (FT3) FT FSH FS046F Growth Hormone HG048H hcg HC047F IgE IE066A Insulin IS098D Insulin (Saliva) IS121D LH LH049F Progesterone PG072S Progesterone for Saliva PG119S Pro-insulin PI099D Prolactin PR063F Prolactin PR063F PTH PT019T Testosterone TE080S Thryoxine (T4) T4105T
3 Page: 3 of 5 Thryoxine (T4) ELISA T4105T Triiodothyronine (T3) T3104T Triiodothyronine (T3) ELISA T3104T TSH TS045T Cancer Markers Beta 2 Microglobulin BM010T AFP AF064T CA 15-3 C19012T CA 19-9 C15013T CA 125 C25011T CEA CE062T Ferritin FR065F Free-beta hcg FB157E Cardiac Markers CKMB CK154C FABP FA155C MPO MP156A Myoglobin MG017C Troponin I TI015C Drug of Abuse Cotinine CO096D Cotinine CO096D Fentanyl FE087D Morphine (Canine) MO091D Autoimmune Disorders ANA Screen IgG AN033G Cardiolipin IgA CA035A Cardiolipin IgG CA034G Cardiolipin IgM CA036M Cardiolipin Total Ab CA077T dsdna IgG DD037G Mitochondrial (MA) Ab MT073G RNP/Sm IgG RN038G
4 Page: 4 of 5 Scl-70 SC043G Sm IgG SM039G SSA IgG SA040G SSB IgG SB041G Thyroglobulin (TG) Ab TG070T Thyroid Peroxidase (TPO) IgG TP069G Infectious Diseases Anthrax IgG AP024G Brucella IgG BA052G Brucella IgM BA053M Dengue Virus IgG DE050G Dengue Virus IgM DE051M EBV-VCA IgA EV011A EBV-VCA IgG EV010G EBV-VCA IgM EV012M H. pylori IgA HP014A H. pylori IgG HP013G H. pylori IgM HP015M HSV-1 IgG H1029G HSV-1 IgM H1030M HSV -2 IgG H2031G HSV-2 IgM H2032M Measles IgG MS018G Measles IgM MS019M Mumps IgG MP060G Mumps IgM MP061M Mycoplasma IgG MP020G Mycoplasma IgM MP021M Salmonella IgG ST093G Salmonella IgM ST084M Treponema pallidum IgG TP076G Treponema pallidum IgM TP089M Treponema pallidum Total TP094T VZV IgG VZ081G VZV IgM VZ082M
5 Page: 5 of 5 Chemilumiscence TESTS (LumELISA) Fertility Markers ACTH Ultra Sensitive lumelisa AC562T ACTH Ultra Sensitive lumelisa AC562T Estradiol Ultra Sensitive lumelisa ES561S FSH Ultra Sensitive lumelisa FS551F LH Ultra Sensitive lumelisa LH550F
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