Trinity Biotech USA
Medical device manufacturer in Jamestown, NY.
11510(k) clearances
0PMA approvals
1recalls
Device types
- LSR Reagent, Borrelia Serological Reagent 2
- DFC Lipoprotein, Low-Density, Antigen… 1
- LLL Extractable Antinuclear Antibody, Antigen… 1
- MJH Legionella, Spp., Elisa 1
- LON System, Test, Automated, Antimicrobial… 1
- LYR Helicobacter Pylori 1
- LJC Enzyme Linked Immunoabsorbent Assay… 1
- MXJ Enzyme Linked Immunosorbent Assay, Herpes… 1
- MYF Enzyme Linked Immunosorbent Assay, Herpes… 1
- PCL Enzyme Linked Immunoabsorbent Assay… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K140455 | Captia Measles IgmPCL · Traditional | 05/22/2014SE |
| K033106 | Captia HSV 2 Igg Type Specific Elisa KitMYF · Traditional | 07/13/2004SE |
| K033105 | Captia HSV 1 Igg Type Specific Elisa KitMXJ · Traditional | 07/13/2004SE |
| K033083 | Borrelia Burgdorferi Igg/Igm Elisa Test SystemLSR · Traditional | 11/26/2003SE |
| K033079 | Chlamydia Igg Elisa Test SystemLJC · Traditional | 11/26/2003SE |
| K033070 | Borrelia Burgdorferi Igm Elisa Test SystemLSR · Traditional | 11/26/2003SE |
| K033067 | Pylori IggLYR · Traditional | 11/26/2003SE |
| K033064 | Mycoplasma IggLON · Traditional | 11/26/2003SE |
| K033051 | Legionella Pneumophila Igg/IgmMJH · Traditional | 11/26/2003SE |
| K993839 | Ena Profile Elisa Test SystemLLL · Traditional | 01/12/2000SE |
| K992665 | Macra Lp(A) Enzyme Immunoassay KitDFC · Traditional | 11/26/1999SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2292-2025 Class II | Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic…Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate… | 07/22/2025Open, Classified |