Trinity Biotech USA is one of 13161 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Trinity Biotech USA - FDA 510(k) Cleared Devices
Recent clearances: CAPTIA MEASLES IGM, ENA PROFILE ELISA TEST SYSTEM, MACRA LP(A) ENZYME IMMUNOASSAY KIT
11
Total
11
Cleared
0
Denied
Trinity Biotech USA has 11 FDA 510(k) cleared microbiology devices. Based in Jamestown, US.
Historical record: 11 cleared submissions from 1999 to 2014.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Trinity Biotech USA
11 devices
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
MYCOPLASMA IGG
Microbiology
58d
Cleared
Nov 26, 2003
PYLORI IGG
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
Cleared
Jan 12, 2000
ENA PROFILE ELISA TEST SYSTEM
Immunology
61d
Cleared
Nov 26, 1999
MACRA LP(A) ENZYME IMMUNOASSAY KIT
Chemistry
109d