Company ยท US
Trinity Biotech USA
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2017. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 4 |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 |
| LYR | Helicobacter Pylori | 2 |
| MJH | Legionella, Spp., Elisa | 2 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 |
| GJS | Test, Time, Prothrombin | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 1 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 1 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 1 |
| MHI | Giardia Spp. | 1 |
| MHJ | Cryptosporidium Spp. | 1 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 1 |
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 1 |
| PCL | Enzyme Linked Immunoabsorbent Assay, Rubeola Igm | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2017 | K172254 | Lyme B. burgdorferi (IgM) MarStripe Test Trinity Biotech | LSR |
| Feb 1, 2017 | K163095 | Lyme B. burgdorferi (IgG) MarStripe Test Trinity Biotech | LSR |
| May 22, 2014 | K140455 | CAPTIA MEASLES IGM Trinity Biotech USA | PCL |
| Mar 1, 2013 | K120001 | UNIGOLD GIARDIA Trinity Biotech | MHI |
| Feb 8, 2013 | K121565 | UNI-GOLD CRYPTOSPORIDIUM Trinity Biotech | MHJ |
| Jul 2, 2009 | K083896 | DESTINY MAX COAGULATION ANALYZER Trinity Biotech | JPA |
| Jul 13, 2004 | K033106 | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT Trinity Biotech USA | MYF |
| Jul 13, 2004 | K033105 | CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT Trinity Biotech USA | MXJ |
| Nov 26, 2003 | K033083 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM Trinity Biotech USA | LSR |
| Nov 26, 2003 | K033079 | CHLAMYDIA IGG ELISA TEST SYSTEM Trinity Biotech USA | LJC |
| Nov 26, 2003 | K033070 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM Trinity Biotech USA | LSR |
| Nov 26, 2003 | K033067 | PYLORI IGG Trinity Biotech USA | LYR |
| Nov 26, 2003 | K033064 | MYCOPLASMA IGG Trinity Biotech USA | LON |
| Nov 26, 2003 | K033059 | HERPES GROUP IGG Trinity Biotech, Inc. | LGC |
| Nov 26, 2003 | K033051 | LEGIONELLA PNEUMOPHILA IGG/IGM Trinity Biotech USA | MJH |
| Jan 24, 2002 | K014233 | CAPTIAM SYPHILIS-G ASSAY Trinity Biotech, Plc, IE | LIP |
| Nov 8, 2001 | K011709 | UNI-GOLD STREP A TEST KIT Trinity Biotech, Plc, IE | GTZ |
| Nov 29, 2000 | K001525 | CAPTIA SYPHILIS-G ELISA TEST SYSTEM Trinity Biotech, Plc | LIP |
| Jan 12, 2000 | K993839 | ENA PROFILE ELISA TEST SYSTEM Trinity Biotech USA | LLL |
| Dec 21, 1999 | K991697 | UNI-GOLD H. PYLORI Trinity Biotech, Plc | LYR |
| Nov 26, 1999 | K992665 | MACRA LP(A) ENZYME IMMUNOASSAY KIT Trinity Biotech USA | DFC |
| Feb 11, 1999 | K982373 | UNI-GOLD STREP A TEST KIT Trinity Biotech, Plc | GTY |
| Aug 8, 1997 | K964424 | ROTAVIRUS EIA Trinity Biotech, Inc. | LIQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2025 | Trinity Biotech USA Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440.
In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease. Open, Classified |
MJH | K991074 |
| Nov 30, 2004 | Trinity Biotech USA AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Responsible firm on the label: Trinity Biotech PLC, I Terminated |
GJS | K972796 |