Trinity Biotech USA
Trinity Biotech USA holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2014, with 1 FDA device recall on record.
Top product codes for Trinity Biotech USA
FDA recalls by Trinity Biotech USA
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Trinity Biotech USA
- K140455 — CAPTIA MEASLES IGM
- K033105 — CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT
- K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT
- K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM
- K033064 — MYCOPLASMA IGG
- K033067 — PYLORI IGG
- K033070 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
- K033079 — CHLAMYDIA IGG ELISA TEST SYSTEM
- K033083 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- K993839 — ENA PROFILE ELISA TEST SYSTEM
- K992665 — MACRA LP(A) ENZYME IMMUNOASSAY KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.