Trinity Biotech, Plc
Medical device manufacturer in Buffalo, NY.
12510(k) clearances
0PMA approvals
0recalls
Device types
- LIP Enzyme Linked Immunoabsorption Assay… 2
- LSR Reagent, Borrelia Serological Reagent 2
- LIQ Enzyme Linked Immunoabsorbent Assay… 1
- GTY Antigens, All Groups, Streptococcus Spp. 1
- LYR Helicobacter Pylori 1
- GTZ Antisera, All Groups, Streptococcus Spp. 1
- LGC Enzyme Linked Immunoabsorbent Assay, Herpes… 1
- JPA System, Multipurpose For In Vitro… 1
- MHJ Cryptosporidium Spp. 1
- MHI Giardia Spp. 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K172254 | Lyme B. burgdorferi (IgM) MarStripe TestLSR · Traditional | 10/23/2017SE |
| K163095 | Lyme B. burgdorferi (IgG) MarStripe TestLSR · Traditional | 02/01/2017SE |
| K120001 | Unigold GiardiaMHI · Traditional | 03/01/2013SE |
| K121565 | Uni-Gold CryptosporidiumMHJ · Traditional | 02/08/2013SE |
| K083896 | Destiny Max Coagulation AnalyzerJPA · Traditional | 07/02/2009SE |
| K033059 | Herpes Group IggLGC · Traditional | 11/26/2003SE |
| K014233 | Captiam Syphilis-G AssayLIP · Special | 01/24/2002SE |
| K011709 | Uni-Gold Strep a Test KitGTZ · Traditional | 11/08/2001SE |
| K001525 | Captia Syphilis-G Elisa Test SystemLIP · Traditional | 11/29/2000SE |
| K991697 | Uni-Gold H. PyloriLYR · Traditional | 12/21/1999SE |
| K982373 | Uni-Gold Strep a Test KitGTY · Traditional | 02/11/1999SE |
| K964424 | Rotavirus EiaLIQ · Traditional | 08/08/1997SE |