Identity
- Trade Name
- AFP FDA UDI
- Generic Name
- Alpha-fetoprotein (AFP) IVD, antibody FDA UDI
- Device Name
- Alternate name : Pan Cytokeratin Plus [AE1/AE3+8/18] FDA UDI
- Model / Reference
- PP028AA FDA UDI
- Description
- Alternate name : Pan Cytokeratin Plus [AE1/AE3+8/18] FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627012081 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Alpha-fetoprotein (AFP) IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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, antibody
Afp by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alpha-fetoprotein (AFP) IVD, antibody.
- Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- FLEX Poly Rb A-Hu Alpha-1-Fetoprotein RTU (Dako Omnis) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- FLEX Poly Rb A-Hu Alpha-1-Fetoprotein RTU (Link) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- IHC — Slmp, LLC · Class I
- Alpha-Fetoprotein (EP209) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (1)
- FDA UDI 76adae15-84ad-4b5d-9730-7707574eb527 34 fields · synced May 30, 2026