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EpCAM|Epithelial Specific Antigen, Ber-EP4, MMab
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref BSB 6279
by Bio SB Inc
Identity
- Trade Name
- EpCAM|Epithelial Specific Antigen, Ber-EP4, MMab EUDAMEDEpCAM/Epithelial Specific Antigen MMab FDA UDI
- Generic Name
- Epithelial specific antigen (ESA) IVD, antibody FDA UDI
- Device Name
- EpCAM|Epithelial Specific Antigen, Ber-EP4, MMab EUDAMEDEpCAM is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
- Model / Reference
- BSB 6279 EUDAMEDConcentrate, 0.5 ml FDA UDI
- Description
- EpCAM is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
Identifiers
- Catalog Number
- BSB 6279 FDA UDI
- Primary DI / UDI-DI
- B502BSB62790 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B502BSB62790 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Epithelial specific antigen (ESA) IVD, antibody FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Sweden 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
EpCAM|Epithelial Specific Antigen, Ber-EP4, MMab by Bio Sb, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-B502BSB62790 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Bio SB Inc
- EUDAMED SRN
- US-MF-000036462
- Authorised Representative
- QAdvis EAR AB SE-AR-000001599
Sources (2)
- EUDAMED 72ce6d0b-bb1c-4730-8fad-a91324268ef5 61 fields · synced Jul 30, 2026
- FDA UDI bcca94e5-886e-46d8-afe9-6aea7a8b4e91 34 fields · synced May 30, 2026