Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1C) analyser IVD FDA UDI
- Device Name
- Tri-stat 2 Analyzer FDA UDI
- Model / Reference
- Tri-stat 2 Analyzer FDA UDI
- Description
- Tri-stat 2 Analyzer FDA UDI
Identifiers
- Catalog Number
- 03-06-0002 FDA UDI
- Primary DI / UDI-DI
- 05391516749473 FDA UDI
- 510(k) Number
- K062658 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1C) analyser IVD 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glycated haemoglobin (HbA1C) analyser IVD
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) analyser IVD.
- VARIANT II TURBO — Bio-Rad Laboratories · Class I
- Glycated Hemoglobin (HbA1C) Analyzer IVD — TOSOH BIOSCIENCE, INC. · Class II
- Tosoh Automated Glycohemoglobin Analyzer HLC-723G8R — TOSOH BIOSCIENCE, INC. · Class II
- D-100 — Bio-Rad Laboratories · Class I
- D-10 — Bio-Rad Laboratories · Class I
- D-10 — Bio-Rad Laboratories · Class I
- ADAMS™ A1c HA-8180V (UL) Analyzer — ARKRAY USA, INC. · Class II
- URIGHT Hemoglobin A1c Analyzer — TAIDOC TECHNOLOGY CORPORATION · Class I
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 36600990-266e-42f2-90ca-b04f372626fd 37 fields · synced May 31, 2026