Identity
- Trade Name
- Direct A1c Reagent Kit FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, reagent FDA UDI
- Model / Reference
- 55370 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700829355 FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, reagent 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, reagent
Direct A1c Reagent Kit by Vitalscientific — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, reagent.
- D-100 — Bio-Rad Laboratories · Class II
- Trinity Biotech — Primus Corp. · Class II
- Trinity Biotech — Primus Corp. · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- ACE — Alfa Wassermann, Inc. · Class II
- Trinity Biotech — Primus Corp. · Class II
- D-10 — Bio-Rad Laboratories · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vitalscientific
Sources (1)
- FDA UDI 2d67339d-78c8-45dd-9a0d-b28ab77359d9 32 fields · synced May 31, 2026