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Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 468R-18Model 468R-1X seriesRef 760-7226
Identity
- Trade Name
- Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody EUDAMEDFDA UDI
- Generic Name
- Claudin protein IVD, antibody FDA UDI
- Device Name
- Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody EUDAMED
- Model / Reference
- 468R-18 EUDAMEDFDA UDI468R-1X series EUDAMED760-7226 EUDAMED468R-14 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061841853732 EUDAMED04065271108967 EUDAMED00841683151586 FDA UDI00841683151623 FDA UDI
- Basic UDI-DI
- 008416831468R-1FG EUDAMED008416831760-72262P EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Claudin 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
- Not 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
EUDAMEDEUDAMED
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
Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
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 d7d3d723-cc8b-4acc-98f4-cf60ff18b819 34 fields · synced Jul 15, 2026
- FDA UDI 34b7ac91-f195-49d0-9e51-aa8dacebd3cd 34 fields · synced May 30, 2026
- EUDAMED 313fb36b-9b63-40c8-afed-abecdd957614 61 fields · synced Jul 9, 2026
- EUDAMED 0a26c1ba-6bc3-4310-a5fd-1d99b9ccdcdf 61 fields · synced Jul 15, 2026