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Hepatocyte Specific Antigen (OCH1E5) Mouse Monoclonal Antibody
EUDAMEDFDA UDIClass C (EU MDR)
Ref 760-4350
Identity
- Trade Name
- Hepatocyte Specific Antigen (OCH1E5) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Hepatocyte specific antigen IVD, antibody FDA UDI
- Device Name
- Hepatocyte Specific Antigen (OCH1E5) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 760-4350 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683100720 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831760-435024 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Hepatocyte specific antigen IVD, antibody FDA UDI
Classification
- Device Class
- Class C 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
New Device
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
Yes
FDA UDI
Hepatocyte Specific Antigen (OCH1E5) Mouse Monoclonal Antibody by Cell Marque Corporation — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 008416831760-435024 | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
- EUDAMED SRN
- US-MF-000028332
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 68087edd-20a4-47d2-adbe-5615a7f979f0 61 fields · synced Jun 19, 2026
- FDA UDI dcb9e318-0d7a-490e-9dae-889bda3fb612 33 fields · synced May 30, 2026