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Trinity Biotech USA

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K033105 CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KITMXJ2004-07-13 View
510(k) K033106 CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KITMYF2004-07-13 View
510(k) K033079 CHLAMYDIA IGG ELISA TEST SYSTEMLJC2003-11-26 View
510(k) K033070 BORRELIA BURGDORFERI IGM ELISA TEST SYSTEMLSR2003-11-26 View
510(k) K033083 BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEMLSR2003-11-26 View
510(k) K033067 PYLORI IGGLYR2003-11-26 View
510(k) K033064 MYCOPLASMA IGGLON2003-11-26 View
510(k) K033051 LEGIONELLA PNEUMOPHILA IGG/IGMMJH2003-11-26 View
510(k) K993839 ENA PROFILE ELISA TEST SYSTEMLLL2000-01-12 View
510(k) K992665 MACRA LP(A) ENZYME IMMUNOASSAY KITDFC1999-11-26 View
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