Identity
- Trade Name
- HIF-1 alpha EUDAMEDFDA UDI
- Generic Name
- Hypoxia-inducible factor 1-alpha (HIF-1-alpha) IVD, antibody FDA UDI
- Device Name
- HIF-1 alpha EUDAMED
- Model / Reference
- CME349A EUDAMEDFDA UDICME349B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627007711 EUDAMEDFDA UDI00847627007728 FDA UDI
- Basic UDI-DI
- B-00847627007711 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
- GMDN Term
- Hypoxia-inducible factor 1-alpha (HIF-1-alpha) IVD, antibody FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
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: Hypoxia-inducible factor 1-alpha (HIF-1-alpha) IVD, antibody
HIF-1 alpha by Biocare Medical, Llc — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hypoxia-inducible factor 1-alpha (HIF-1-alpha) IVD, antibody.
- ANTI-HIF 2 — Biogenex Laboratories, Inc. · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (3)
- FDA UDI 72dc8d38-3830-4a35-8a08-785f788e3ecc 33 fields · synced Sep 30, 2026
- FDA UDI 0b94bc67-3a9e-4902-baca-3fac984def1a 33 fields · synced May 30, 2026
- EUDAMED 3ab12b18-599c-42f1-97a7-d868c606cfb4 61 fields · synced Sep 17, 2026