CEA Rabbit Polyclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- CEA Rabbit Polyclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Carcinoembryonic antigen (CEA) IVD, antibody FDA UDI
- Device Name
- CEA Rabbit Polyclonal Antibody EUDAMED
- Model / Reference
- 236A-15 EUDAMEDFDA UDI236A-18 EUDAMEDFDA UDI236A-1X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683129073 EUDAMEDFDA UDI00841683129103 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831236A-1AJ EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Carcinoembryonic antigen (CEA) 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Carcinoembryonic antigen (CEA) IVD, antibody
CEA Rabbit Polyclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (4)
- FDA UDI 10015fdd-4a5b-45c4-b787-9cbea458030d 33 fields · synced Jul 9, 2026
- FDA UDI 6b71a644-db98-4bbc-aece-3ba7ee1810ba 33 fields · synced May 25, 2026
- EUDAMED f30e7a70-5ebb-4de8-b569-ac1fbe3380cd 61 fields · synced Jul 9, 2026
- EUDAMED 0fc4ed69-c5b1-4285-b2a9-081e5400165b 61 fields · synced Jul 9, 2026