Identity
- Trade Name
- HbA1c CALIBRATOR SET FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
- Model / Reference
- HBAC-0043 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700828709 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
HbA1c CALIBRATOR SET by Vitalscientific — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Chemistry HbA1c Calibrator Kit — Medica Corp. · Class II
- VARIANT II — Bio-Rad Laboratories · Class I
- 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 3a90f58d-49ed-4559-94d0-95c1c44c76da 32 fields · synced May 30, 2026