Tinto CD38, SPC32, MMab
EUDAMEDFDA UDIClass IVD General (EU MDR)
by Bio SB Inc
Identity
- Trade Name
- Tinto CD38, SPC32, MMab EUDAMEDTinto CD38 RMab FDA UDI
- Generic Name
- CD38 cell marker IVD, antibody FDA UDI
- Device Name
- Tinto CD38, SPC32, MMab EUDAMEDTinto CD38 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 6198 EUDAMEDPredilute, 3 ml FDA UDI
- Description
- Tinto CD38 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 6198 FDA UDI
- Primary DI / UDI-DI
- B502BSB61980 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B502BSB61980 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- CD38 cell marker 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
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
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Tinto CD38, SPC32, MMab medical device is a cutting-edge implantable solution for treating endocrine disorders. This innovative device features a unique combination of bioactive peptides and microspheres to restore hormone balance in patients.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-B502BSB61980 | 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 e376bda0-376a-4095-b078-02885bf5580c 61 fields · synced Jul 1, 2026
- FDA UDI e34045d5-b43e-4e74-a0f7-d52db4105e36 34 fields · synced May 30, 2026