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US
Last updated May 24, 2026
What TRINITY BIOTECH PUBLIC LIMITED COMPANY makes
Trinity Biotech Public Limited Company manufactures in vitro diagnostic reagents and kits for measuring red cell glucose-6-phosphate dehydrogenase (G6PD) activity, oxalate levels, and total bile acid concentrations. These products include enzyme spectrophotometry kits, reagents, calibrators, and controls designed for clinical laboratory use.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA's Unique Device Identification (FDA UDI) system. Trinity Biotech Public Limited Company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Trinity Biotech Public Limited Company make?
Trinity Biotech Public Limited Company manufactures in vitro diagnostic reagents and kits for measuring red cell glucose-6-phosphate dehydrogenase (G6PD) activity, oxalate levels, and total bile acid concentrations. These products include enzyme spectrophotometry kits, reagents, calibrators, and controls designed for clinical laboratory use, as specified in the device data.
Where is Trinity Biotech Public Limited Company based?
Trinity Biotech Public Limited Company is based in the United States, as stated in the country field of the device data, which identifies its location without implying any regulatory approval or certification of the company itself.
Which registries list Trinity Biotech's devices?
Trinity Biotech's devices are listed in the FDA's Unique Device Identification (FDA UDI) system, as indicated in the LISTED IN field of the device data, which confirms their inclusion in this specific regulatory registry without asserting broader approvals or clearances.
How are Trinity Biotech's devices classified?
Trinity Biotech's devices are classified as Class I and Class II medical devices, according to the DEVICE CLASSES field in the device data, which reflects their risk-based categorization under regulatory frameworks without implying that the company or its devices as a whole are approved or cleared.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- trinitybiotech.com
- —
- —
- [email protected]
- Phone
- +35312769800
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 988298840
Catalogue (49)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bartels® | B1029-44C | FDA UDI | Class II | Unknown |
| Bartels® | B1029-47B | FDA UDI | Class II | Unknown |
| Trinity Biotech | 591-20 | FDA UDI | Class I | Active |
| Trinity Biotech | 450-11 | FDA UDI | Class II | Active |
| Bartels® | B1029-44 | FDA UDI | Class II | Unknown |
| Trinity Biotech | 345-B | FDA UDI | Class II | Active |
| Bartels® | B1029-47 | FDA UDI | Class II | Unknown |
| MicroTrak® | 8H399UL | FDA UDI | Class II | Unknown |
| Trinity Biotech | 591-11 | FDA UDI | Class I | Active |
| Bartels® | B1029-47C | FDA UDI | Class II | Unknown |
| Bartels® | B1029-81A | FDA UDI | Class II | Unknown |
| Trinity Biotech | 305-10 | FDA UDI | Class II | Active |
| Trinity Biotech | 591-3 | FDA UDI | Class I | Active |
| Trinity Biotech | 400K-100X | FDA UDI | Class II | Active |
| Trinity Biotech | 400-4-50 | FDA UDI | Class II | Active |
| Trinity Biotech | 400-5x10 | FDA UDI | Class II | Active |
| Trinity Biotech | 400-10x10 | FDA UDI | Class II | Active |
| Trinity Biotech | 203-A | FDA UDI | Class II | Active |
| MicroTrak® | 8H329UL | FDA UDI | Class II | Unknown |
| Trinity Biotech | 826-10 | FDA UDI | Class I | Unknown |
| Trinity Biotech | 450-2-25 | FDA UDI | Class II | Active |
| Trinity Biotech | 450-A | FDA UDI | Class II | Active |
| MicroTrak® | 8H219UL | FDA UDI | Class II | Unknown |
| Bartels® | B1029-81B | FDA UDI | Class II | Unknown |
| Trinity Biotech | 450-100 | FDA UDI | Class II | Active |
| Trinity Biotech | 591-C | FDA UDI | Class I | Active |
| Trinity Biotech | 591-10 | FDA UDI | Class I | Active |
| Trinity Biotech | 591-100 | FDA UDI | Class I | Active |
| Trinity Biotech | 400K-100-5X20 | FDA UDI | Class II | Active |
| Trinity Biotech | 450-22 | FDA UDI | Class I | Active |
| Trinity Biotech | 450-2 | FDA UDI | Class II | Active |
| Trinity Biotech | 591-4 | FDA UDI | Class I | Active |
| Trinity Biotech | R1129 | FDA UDI | Class II | Active |
| Trinity Biotech | 345-A | FDA UDI | Class II | Active |
| Trinity Biotech | 591-2 | FDA UDI | Class I | Active |
| Bartels® | B1029-81 | FDA UDI | Class II | Unknown |
| Uni-Gold™ | 1206530 | FDA UDI | Class II | Unknown |
| MicroTrak® | 8H349UL | FDA UDI | Class II | Unknown |
| Trinity Biotech | O6627 | FDA UDI | Class I | Active |
| Trinity Biotech | 400-5-1000 | FDA UDI | Class II | Active |
| Trinity Biotech | O6502 | FDA UDI | Class I | Active |
| Trinity Biotech | 591-4-1000 | FDA UDI | Class I | Active |
| Uni-Gold™ | 1206506 | FDA UDI | Class II | Unknown |
| Trinity Biotech | 450-3 | FDA UDI | Class II | Active |
| Trinity Biotech | 591-D | FDA UDI | Class I | Active |
| Trinity Biotech | 400-5-100 | FDA UDI | Class II | Active |
| Trinity Biotech | 450-1-50 | FDA UDI | Class II | Active |
| Bartels® | B1029-48 | FDA UDI | Class II | Unknown |
| Bartels® | B1029-91 | FDA UDI | Class II | Unknown |
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