Identity
- Trade Name
- Direct A1c Calibrator Kt FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
- Model / Reference
- 55120 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700829331 FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
Classification
- 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
No
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, calibrator
Direct A1c Calibrator Kt by Vitalscientific — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Trinity Biotech — Primus Corp. · Class II
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Vitalscientific
Sources (1)
- FDA UDI b130a976-fb54-46c1-99be-bb8ccc6b490b 32 fields · synced Jun 8, 2026