# Trinity Biotech, Plc

- Location (FDA's records): Jamestown, NY
- FDA decisions: 12 (1997–2017): 12 510(k) clearances
- Names in FDA's records: Trinity Biotech, Plc (5); Trinity Biotech (5); Trinity Biotech, Inc. (2)
- Product codes: LIP (2), LSR (2), GTZ (1), LYR (1), LGC (1), MHJ (1), LIQ (1), GTY (1), MHI (1), JPA (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Remel Co.: 2 (https://510kreport.com/company/remel)
- Mardx Diagnostics, Inc.: 2 (https://510kreport.com/company/mardx-diagnostics)
- Sigma Diagnostics, Inc.: 1 (https://510kreport.com/company/sigma-diagnostics)

## Firms that cite its devices most
- DiaSorin, Inc.: 1 (https://510kreport.com/company/diasorin)

## Its most-cited devices
- K014233: Captiam Syphilis-G Assay (2002), cited by 1

## Recent decisions
- K172254: Lyme B. burgdorferi (IgM) MarStripe Test (Oct 23, 2017)
- K163095: Lyme B. burgdorferi (IgG) MarStripe Test (Feb 1, 2017)
- K120001: Unigold Giardia (Mar 1, 2013)
- K121565: Uni-Gold Cryptosporidium (Feb 8, 2013)
- K083896: Destiny Max Coagulation Analyzer (Jul 2, 2009)
- K033059: Herpes Group Igg (Nov 26, 2003)
- K014233: Captiam Syphilis-G Assay (Jan 24, 2002)
- K011709: Uni-Gold Strep a Test Kit (Nov 8, 2001)

Source page: https://510kreport.com/company/trinity-biotech