Ep-CAM/Epithelial Specific Antigen (MOC-31) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Ep-CAM/Epithelial Specific Antigen (MOC-31) Mouse Monoclonal Antibody EUDAMEDFDA UDIEp-CAM/Epithelial Specific Antigen (MOC-31) Mouse Monoclonal Antibody FDA UDI
- Generic Name
- Epithelial cell adhesion molecule (EpCAM) IVD, antibody FDA UDI
- Device Name
- Ep-CAM/Epithelial Specific Antigen (MOC-31) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Model / Reference
- 248M-15 EUDAMEDFDA UDI248M-10 EUDAMEDFDA UDI248M-16 EUDAMEDFDA UDI248M-1X series EUDAMED248M-18 FDA UDI
- Description
- Ep-CAM/Epithelial Specific Antigen (MOC-31) Mouse Monoclonal Antibody FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683130185 EUDAMEDFDA UDI00841683130161 EUDAMEDFDA UDI00841683130192 EUDAMEDFDA UDI00841683130215 FDA UDI
- Basic UDI-DI
- 008416831248M-1D7 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Epithelial cell adhesion molecule (EpCAM) 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: Epithelial cell adhesion molecule (EpCAM) IVD, antibody
Ep-CAM/Epithelial Specific Antigen (MOC-31) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Epithelial cell adhesion molecule (EpCAM) IVD, antibody.
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- MOC-31 — BIOCARE MEDICAL, LLC · Class I
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- Mouse Monoclonal Anti-Human Ep-CAM(MX066) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
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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 (7)
- FDA UDI b3cccfcb-68e6-4696-8f5d-1b4a30bcd9b0 34 fields · synced Jul 17, 2026
- FDA UDI d1b23dab-60bf-49c8-a0fd-fecc9630463a 34 fields · synced May 29, 2026
- FDA UDI 0cb58a85-3da5-4bbc-9fa5-cb66e839a05f 34 fields · synced May 30, 2026
- FDA UDI 1fd2a5ea-cb30-40a8-851a-28bf3cc2d2a7 34 fields · synced May 30, 2026
- EUDAMED 42763164-468c-4e9f-8a8e-5c1d3f38c497 61 fields · synced Jul 9, 2026
- EUDAMED 35ad5998-532c-48f7-b640-67981ae1ba5d 61 fields · synced Jul 14, 2026
- EUDAMED 752866dc-f5c8-41cd-80e2-78113af9b182 61 fields · synced Jul 17, 2026