Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody
Ref 760-7226
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number04065271108967 | Date4 Sep 2026 | StatusListed |
| European Union | CE/IVDR EUDAMED | Number008416831760-72262P 04065271108967 | Date8 May 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody EUDAMEDClaudin-4 (EP417) Rabbit Monoclonal Antibody GUDID
- Generic Name
- Claudin protein IVD, antibody
- Model / Reference
- 760-7226
- Primary DI / UDI-DI
- 04065271108967
- Basic UDI-DI
- 008416831760-72262P
- FDA Product Code
- NJT
- EMDN Code
- W01030709 Primary antisera for immunohistology
- GMDN Term
- Claudin protein IVD, antibody
- Device Class
- Class C EUDAMEDClass I GUDID
- Regulation Number
- 864.1860
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class C | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000028332
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Cell Marque Corporation
Properties
Other properties (17)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No