Medical Device Manufacturer · US , Jamestown , NY

Trinity Biotech USA - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1999

Recent clearances: CAPTIA MEASLES IGM, CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT, CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT

View 11 510(k) Devices ↓

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Trinity Biotech USA Chemistry ✕

1 devices

1-1 of 1

Cleared Nov 26, 1999

MACRA LP(A) ENZYME IMMUNOASSAY KIT

Chemistry · 109d