Tinto ROS-1, EP282, RMab
EUDAMEDFDA UDIClass IVD General (EU MDR)
by Bio SB Inc
Identity
- Trade Name
- Tinto ROS-1, EP282, RMab EUDAMEDTinto ROS-1, RMab FDA UDI
- Generic Name
- Proto-oncogene tyrosine-protein kinase ROS (ROS1) IVD, antibody FDA UDI
- Device Name
- Tinto ROS-1, EP282, RMab EUDAMEDTinto ROS-1 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 3623 EUDAMEDPredilute, 3 ml FDA UDI
- Description
- Tinto ROS-1 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 3623 FDA UDI
- Primary DI / UDI-DI
- B502BSB36230 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B502BSB36230 EUDAMED
- FDA Product Code
- MVU FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Proto-oncogene tyrosine-protein kinase ROS (ROS1) 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
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
No
Manufacturing Date
No
The Tinto ROS-1, EP282, RMab device is a medical product designed for the treatment of ear disorders. It features a sterile implantable design, with QAdvis EAR AB as its primary actor name in human product testing. The device has undergone various updates and revisions, including changes to its nominal code, identifier, and version number.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-B502BSB36230 | 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 52c55f4c-7ef3-427f-b97a-f346759fc49c 61 fields · synced Jun 22, 2026
- FDA UDI 0a9be5d0-7c32-404e-a236-124c3fc36629 34 fields · synced May 30, 2026