Medical Device Manufacturer · US , Jamestown , NY

Trinity Biotech USA - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1999

11

Total

11

Cleared

0

Denied

Trinity Biotech USA — FDA 510(k) Products and Clearance History Microbiology ✕

9 devices

1-9 of 9

Cleared May 22, 2014

CAPTIA MEASLES IGM

Microbiology · 87d

Cleared Jul 13, 2004

CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT

Microbiology · 287d

Cleared Jul 13, 2004

CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT

Microbiology · 287d

Cleared Nov 26, 2003

LEGIONELLA PNEUMOPHILA IGG/IGM

Microbiology · 58d

Cleared Nov 26, 2003

Microbiology · 58d

Cleared Nov 26, 2003

Microbiology · 58d

Cleared Nov 26, 2003

BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM

Microbiology · 58d

Cleared Nov 26, 2003

CHLAMYDIA IGG ELISA TEST SYSTEM

Microbiology · 58d

Cleared Nov 26, 2003

BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM

Microbiology · 58d