Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Inherited haemoglobinopathy IVD, kit, liquid chromatography FDA UDI
- Device Name
- Hemoglobin variants assay, Ultra2 Resolution Variants Analyzer FDA UDI
- Model / Reference
- Ultra2 Resolution Variants Analyzer FDA UDI
- Description
- Hemoglobin variants assay, Ultra2 Resolution Variants Analyzer FDA UDI
Identifiers
- Catalog Number
- 03-01-0053 FDA UDI
- Primary DI / UDI-DI
- 05391516748179 FDA UDI
- 510(k) Number
- K955283 FDA UDI
- FDA Product Code
- GKA FDA UDI
- GMDN Term
- Inherited haemoglobinopathy IVD, kit, liquid chromatography FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7415 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: Inherited haemoglobinopathy IVD, kit, liquid chromatography
Trinity Biotech by Primus Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Hemoglobin Variants System — Bio-Rad Laboratories · Class II
- Trinity Biotech — Primus Corp. · Class II
Cleared under the same submission
K955283 also covers:
- Trinity Biotech — Primus Corp.
- Trinity Biotech — Primus Corp.
- Trinity Biotech — Primus Corp.
- Trinity Biotech — Primus Corp.
- Trinity Biotech — Primus Corp.
- Trinity Biotech — Primus Corp.
- Trinity Biotech — Primus Corp.
- Trinity Biotech — Primus Corp.
- Trinity Biotech — Primus Corp.
- Trinity Biotech — Primus Corp.
- Trinity Biotech — Primus Corp.
- Trinity Biotech — Primus Corp.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Primus Corp.
Sources (1)
- FDA UDI 582a40e6-3153-4ae7-85e3-0a76c45a6098 37 fields · synced Jun 1, 2026