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Last updated May 23, 2026
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Catalogue (72)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Trinity Biotech | Ultra2 Affinity A1c 3000 | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Hb9210 HbA1c Analytical Column (500) | FDA UDI | Class II | Active |
| Trinity Biotech | HbA1c (GHb) Calibrator Kit, 400uL (Levels 1 & 2) - 1 kit | FDA UDI | Class II | Active |
| Trinity Biotech | Ultra2 Genesys Variants Analyzer | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Buffer B Reagent - 3.8L | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Buffer A Plus Reagent - 3.8 L | FDA UDI | Class II | Active |
| Trinity Biotech | Ultra2 Buffer 2A Reagent - 3.8L | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Affinity A1c 500 - 1 kit | FDA UDI | Class II | Active |
| Trinity Biotech | 2 Diluent Reagent - 940mL | FDA UDI | Class II | Active |
| Trinity Biotech | Ultra2 Affinity HbA1c Analyzer (220V) | FDA UDI | Class II | Active |
| Trinity Biotech | Affinity Analytical Column | FDA UDI | Class II | Active |
| Trinity Biotech | Ultra2 Resolution Variants Analyzer | FDA UDI | Class II | Active |
| Trinity Biotech | Ultra2 Buffer B Reagent - 3.8L | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Hb9210 HbA1c Analyzer - 1 each | FDA UDI | Class II | Active |
| Trinity Biotech | HbA1c (GHb) Controls Kit, 400uL (Levels I & II) - 1 kit | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Hb9210 HbA1c Analytical Column (1500) | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Resolution A2+F Control Material Kit | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Buffer B Reagent - 940mL | FDA UDI | Class II | Active |
| Trinity Biotech | A2+F Control Material Kit | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Diluent Reagent - 3.8L | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Hb9210 HbA1c Analytical Column (1000) | FDA UDI | Class II | Active |
| Trinity Biotech | Genesys 2 Reagent - 3.8L | FDA UDI | Class II | Active |
| Trinity Biotech | Resolution Analytical Column | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Buffer A Reagent - 940mL | FDA UDI | Class II | Active |
| Trinity Biotech | HbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 1 kit | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Hb9210 HbA1c Analytical Column (2500) | FDA UDI | Class II | Active |
| Trinity Biotech | Tri-stat Liquid Controls Kit | FDA UDI | Class I | Active |
| Trinity Biotech | Premier Sample Diluent Reagent - 940mL | FDA UDI | Class II | Active |
| Trinity Biotech | Genesys Analytical Column | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Buffer A Plus Reagent - 940 mL | FDA UDI | Class II | Active |
| Trinity Biotech | FASC Position Marker Kit | FDA UDI | Class II | Active |
| Trinity Biotech | Enzyme Cleaner Tube | FDA UDI | Class II | Active |
| Trinity Biotech | Tri-stat Reagent Kit | FDA UDI | Class II | Active |
| Trinity Biotech | Genesys Diluent Reagent - 3.8L | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Resolution A2+F Calibrator Kit | FDA UDI | Class II | Active |
| Trinity Biotech | Ultra2 Buffer B Reagent - 940mL | FDA UDI | Class II | Active |
| Trinity Biotech | 2 Diluent Reagent - 3.8L | FDA UDI | Class II | Active |
| Trinity Biotech | System Wash Reagent - 940mL | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Buffer A Reagent - 3.8L | FDA UDI | Class II | Active |
| Trinity Biotech | Ultra2 Affinity HbA1c Analyzer (110V) | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Affinity A1c 1000 - 1 kit | FDA UDI | Class II | Active |
| Trinity Biotech | Premier Affinity A1c 3000 - 1 kit | FDA UDI | Class II | Active |
| Trinity Biotech | Mobile Phase 2 Reagent - 3.8L | FDA UDI | Class II | Active |
| Trinity Biotech | Ultra2 Buffer 2A Reagent - 940mL | FDA UDI | Class II | Active |
| Trinity Biotech | Mobile Phase 2 Reagent - 940mL | FDA UDI | Class II | Active |
| Trinity Biotech | PDQ1 Reagent - 940mL | FDA UDI | Class II | Active |
| Trinity Biotech | Ultra2 Resolution 500 | FDA UDI | Class II | Active |
| Trinity Biotech | Mobile Phase 1 Reagent - 940mL | FDA UDI | Class II | Active |
| Trinity Biotech | Mobile Phase 1 Reagent - 3.8L | FDA UDI | Class II | Active |
| Trinity Biotech | PDQ 2 Reagent - 940mL | FDA UDI | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 9, 2020 | Z-0321-2021 | — | terminated | The product did not receive pre-market approval or clearance. |