Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Hemoglobin A1c assay, Tri-stat Reagent Kit FDA UDI
- Model / Reference
- Tri-stat Reagent Kit FDA UDI
- Description
- Hemoglobin A1c assay, Tri-stat Reagent Kit FDA UDI
Identifiers
- Catalog Number
- 03-06-0010 FDA UDI
- Primary DI / UDI-DI
- 05391516748223 FDA UDI
- 510(k) Number
- K062658 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, kit, chemiluminescent immunoassay
Trinity Biotech by Primus Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, kit, chemiluminescent immunoassay.
- VITROS — Ortho-Clinical Diagnostics · Class II
Cleared under the same submission
K062658 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Primus Corp.
Sources (1)
- FDA UDI a315c3b4-cdca-43c6-85f1-6919ed7a7ea3 37 fields · synced May 30, 2026