Trinity Biotech, PLC
BRAY Wicklow, IE
TRINITY BIOTECH, PLC appears in FDA device records in BRAY Wicklow, IE. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Trinity Biotech, PLC between 1997 and 2017. The busiest year on record is 1999, with 2. The most recent is 2017, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2009 | 1 |
| 2013 | 2 |
| 2017 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172254 | Lyme B. burgdorferi (IgM) MarStripe Test | LSR | Substantially Equivalent | |
| K163095 | Lyme B. burgdorferi (IgG) MarStripe Test | LSR | Substantially Equivalent | |
| K120001 | UNIGOLD GIARDIA | MHI | Substantially Equivalent | |
| K121565 | UNI-GOLD CRYPTOSPORIDIUM | MHJ | Substantially Equivalent | |
| K083896 | DESTINY MAX COAGULATION ANALYZER | JPA | Substantially Equivalent | |
| K033059 | HERPES GROUP IGG | LGC | Substantially Equivalent | |
| K014233 | CAPTIAM SYPHILIS-G ASSAY | LIP | Substantially Equivalent | |
| K011709 | UNI-GOLD STREP A TEST KIT | GTZ | Substantially Equivalent | |
| K001525 | CAPTIA SYPHILIS-G ELISA TEST SYSTEM | LIP | Substantially Equivalent | |
| K991697 | UNI-GOLD H. PYLORI | LYR | Substantially Equivalent | |
| K982373 | UNI-GOLD STREP A TEST KIT | GTY | Substantially Equivalent | |
| K964424 | ROTAVIRUS EIA | LIQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9681576 | 3002546385 | TRINITY BIOTECH, PLC | IDA BUSINESS PARK, BRAY Wicklow -- IE | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GTYAntigens, All Groups, Streptococcus Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- JITCalibrator, Secondary
- MHJCryptosporidium Spp.
- JSMCulture Media, Non-Propagating Transport
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
- MHIGiardia Spp.
- JBLGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
- JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
- JBGGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot
- LYRHelicobacter Pylori
- KQNRadioassay, Angiotensin Converting Enzyme
- KWWRadioimmunoassay, Cholyglycine, Bile Acids
- LSRReagent, Borrelia Serological Reagent
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KSKSolution, Stabilized Enzyme
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- LPWSystem, Test, Oxalate
- MYPTest, Platelet Antibody
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain