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P504s (13H4) Rabbit Monoclonal Antibody
EUDAMEDFDA UDIClass C (EU MDR)
Ref 504R-16Model 504R-1X series
Identity
- Trade Name
- P504s (13H4) Rabbit Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- p504s protein IVD, antibody FDA UDI
- Device Name
- P504s (13H4) Rabbit Monoclonal Antibody EUDAMED
- Model / Reference
- 504R-1X series EUDAMED504R-16 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04065265824989 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831504R-1CX EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- p504s protein 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
No
FDA UDI
P504s (13H4) Rabbit Monoclonal Antibody by Cell Marque Corporation — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 008416831504R-1CX | 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 d7f86e94-c1c6-48c4-a8d0-2e3d7d66a063 61 fields · synced Jun 20, 2026
- FDA UDI 0304b8f7-53dd-41b9-8851-6eb642eb244d 33 fields · synced May 30, 2026