Identity
- Trade Name
- AutoDELFIA hAFP kit FDA UDI
- Generic Name
- Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Time-resolved fluoroimmunoassay for the quantitative determination of human alphafetoprotein (hAFP) FDA UDI
- Model / Reference
- B079-212 FDA UDI
- Description
- Time-resolved fluoroimmunoassay for the quantitative determination of human alphafetoprotein (hAFP) FDA UDI
Identifiers
- Catalog Number
- B079-212 FDA UDI
- Primary DI / UDI-DI
- 06438147321322 FDA UDI
- PMA Number
- P970037 FDA UDI
- FDA Product Code
- LOK FDA UDI
- GMDN Term
- Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class III 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
No
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: Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay
AutoDELFIA hAFP kit by Wallac, Inc. — Class III — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Wallac, Inc.
Sources (2)
- FDA UDI 20a694f7-f6b6-4f8b-88b8-abe76859a464 36 fields · synced May 31, 2026
- EUDAMED 1 fields · synced May 22, 2026