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HER2 neu, EP3, RMab
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref BSB 2514
by Bio SB Inc
Identity
- Trade Name
- HER2 neu, EP3, RMab EUDAMEDHER2 neu RMab FDA UDI
- Generic Name
- Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody FDA UDI
- Device Name
- HER2 neu, EP3, RMab EUDAMEDHER-2 neu is a rabbit 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 2514 EUDAMEDConcentrate, 0.5 ml FDA UDI
- Description
- HER-2 neu is a rabbit 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 2514 FDA UDI
- Primary DI / UDI-DI
- B502BSB25140 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B502BSB25140 EUDAMED
- FDA Product Code
- MVU FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4020 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
HER2 neu, EP3, RMab by Bio Sb, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-B502BSB25140 | 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 252a8927-03c4-40b4-9c6a-672aa8ba5b17 61 fields · synced Jul 9, 2026
- FDA UDI c5f6d039-2a5e-4447-82e6-c6dd29b2e12f 34 fields · synced May 30, 2026