Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Vitamin B12 IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit FDA UDI
- Model / Reference
- 3P24-25 FDA UDI
- Description
- ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit FDA UDI
Identifiers
- Catalog Number
- 03P2425 FDA UDI
- Primary DI / UDI-DI
- 00380740006365 FDA UDI
- FDA Product Code
- JIT FDA UDIJJX FDA UDICDD FDA UDI
- GMDN Term
- Vitamin B12 IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI862.1660 FDA UDI862.1810 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
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: Vitamin B12 IVD, kit, chemiluminescent immunoassay
Architect by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Abbott
Sources (1)
- FDA UDI ab0bed7d-be7a-43d0-b331-aae8eac8f982 36 fields · synced May 31, 2026