Data / Medical devices / Ireland / Trinity Biotech, Plc
Trinity Biotech, Plc: FDA-registered device maker in BRAY Wicklow, Ireland, 8 510(k) clearances
Trinity Biotech, Plc is registered with the FDA (registration 9681576) in BRAY Wicklow, Ireland. It lists 12 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 29, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681576
- FEI number
- 3002546385
- Address
- Ida Business Park, BRAY Wicklow, Ireland, --
- Owner or operator
- TRINITY BIOTECH, PLC (9025161)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 18, 2004
- Registered through
- 2026
- Brand names listed
- Bartels Flex Trans Medium, IMMUCOR GAMMA Freeze Dried Papain, IMMUCOR GAMMA Human Platelet Concebtrate, IMMUCOR GAMMA W.A.R.M. (Warm Autoantibody Removal Medium), Trinity Biotech
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Secondary | JIT | 2 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Propagating Transport | JSM | 1 | Contract manufacturer | accessdata.fda.gov |
| Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative | JBL | 2 | Manufacturer | accessdata.fda.gov |
| Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | JBF | 2 | Manufacturer | accessdata.fda.gov |
| Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot | JBG | 2 | Manufacturer | accessdata.fda.gov |
| Radioassay, Angiotensin Converting Enzyme | KQN | 2 | Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Cholyglycine, Bile Acids | KWW | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| Solution, Stabilized Enzyme | KSK | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Test, Oxalate | LPW | 1 | Manufacturer | accessdata.fda.gov |
| Test, Platelet Antibody | MYP | 2 | Contract manufacturer | accessdata.fda.gov |
| Urinalysis Controls (Assayed And Unassayed) | JJW | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 29, 1995 | K933934 | GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A | JBF | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| October 25, 1988 | K883525 | OXALATE REAGENT | LPW | Substantially Equivalent | Sigma Chemical Co. | accessdata.fda.gov |
| October 20, 1987 | K873342 | BILE ACIDS CONTROLS | JJX | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| August 26, 1987 | K872296 | BILE ACIDS REAGENT | KWW | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| August 21, 1987 | K872451 | BILE ACIDS CALIBRATOR | JIT | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| January 22, 1986 | K854245 | SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV | KQN | Substantially Equivalent | Sigma Diagnostics, Inc. | accessdata.fda.gov |
| September 12, 1984 | K842366 | OXALATE URINE CONTROLS NORMAL & ELEVAT | JJW | Substantially Equivalent | Sigma Chemical Co. | accessdata.fda.gov |
| March 15, 1979 | K790211 | DEHYDROGENOSE, GLUCOSE PHOSPHATE | JBL | Substantially Equivalent | Sigma Chemical Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
- All makers of Solution, Stabilized Enzyme
- All makers of Radioimmunoassay, Cholyglycine, Bile Acids
Updated June 29, 1995. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.