# Trinity Biotech USA

- Location (FDA's records): Jamestown, NY
- FDA decisions: 11 (1999–2014): 11 510(k) clearances
- Product codes: LSR (2), MXJ (1), DFC (1), PCL (1), LON (1), MJH (1), MYF (1), LJC (1), LLL (1), LYR (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gull Laboratories, Inc.: 1 (https://510kreport.com/company/gull-laboratories)

## Firms that cite its devices most
- Gold Standard Diagnostics: 2 (https://510kreport.com/company/gold-standard-diagnostics)
- Dade Behring, Inc.: 1 (https://510kreport.com/company/dade-behring)

## Its most-cited devices
- K033070: Borrelia Burgdorferi Igm Elisa Test System (2003), cited by 2
- K992665: Macra LP (a) Enzyme Immunoassay Kit (1999), cited by 1

## Recent decisions
- K140455: Captia Measles Igm (May 22, 2014)
- K033105: Captia HSV 1 Igg Type Specific Elisa Kit (Jul 13, 2004)
- K033106: Captia HSV 2 Igg Type Specific Elisa Kit (Jul 13, 2004)
- K033064: Mycoplasma Igg (Nov 26, 2003)
- K033083: Borrelia Burgdorferi Igg/Igm Elisa Test System (Nov 26, 2003)
- K033070: Borrelia Burgdorferi Igm Elisa Test System (Nov 26, 2003)
- K033051: Legionella Pneumophila Igg/Igm (Nov 26, 2003)
- K033079: Chlamydia Igg Elisa Test System (Nov 26, 2003)

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