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Tinto HE4, EP370, RMab
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref BSB 3350
by Bio SB Inc
Identity
- Trade Name
- Tinto HE4, EP370, RMab EUDAMEDTinto HE4, RMab FDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Tinto HE4, EP370, RMab EUDAMEDHE4 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 3350 EUDAMEDPredilute, 7 ml FDA UDI
- Description
- HE4 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 3350 FDA UDI
- Primary DI / UDI-DI
- B502BSB33500 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B502BSB33500 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Tinto HE4, EP370, 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-B502BSB33500 | 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 3d51db3d-7fc5-4fc3-b6e1-7b20e3d3f3a1 61 fields · synced Jul 29, 2026
- FDA UDI 54f656cd-1039-40a5-a24a-ad1a9ad5039c 34 fields · synced May 30, 2026