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Tinto CD117, EP10, RMab
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref BSB 5316
by Bio SB Inc
Identity
- Trade Name
- Tinto CD117, EP10, RMab EUDAMEDTinto CD117 RMab FDA UDI
- Generic Name
- CD117 (c-kit) cell marker IVD, antibody FDA UDI
- Device Name
- Tinto CD117, EP10, RMab EUDAMEDCD117 is rabbit monoclonal antibody from supernatant diluted in Phosphate Buffered Saline, pH 7.6, with protein base, and preserved with Sodium Azide preservative. FDA UDI
- Model / Reference
- BSB 5316 EUDAMEDPredilute, 3 ml FDA UDI
- Description
- CD117 is rabbit monoclonal antibody from supernatant diluted in Phosphate Buffered Saline, pH 7.6, with protein base, and preserved with Sodium Azide preservative. FDA UDI
Identifiers
- Catalog Number
- BSB 5316 FDA UDI
- Primary DI / UDI-DI
- B502BSB53160 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B502BSB53160 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- CD117 (c-kit) 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
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 CD117, EP10, 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-B502BSB53160 | 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 40c05a3e-bbbc-47c7-9654-69b0ddf08486 61 fields · synced Jun 19, 2026
- FDA UDI 8eb64939-9ffd-49da-8b89-28af4c24313f 34 fields · synced May 30, 2026