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Tinto CEA, Polyclonal, RPab
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref BSB 6535
by Bio SB Inc
Identity
- Trade Name
- Tinto CEA, Polyclonal, RPab EUDAMEDTinto CEA RMab FDA UDI
- Generic Name
- Carcinoembryonic antigen (CEA) IVD, antibody FDA UDI
- Device Name
- Tinto CEA, Polyclonal, RPab EUDAMEDCEA is a rabbit polyclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
- Model / Reference
- BSB 6535 EUDAMEDPredilute, 7 ml FDA UDI
- Description
- CEA is a rabbit polyclonal 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 6535 FDA UDI
- Primary DI / UDI-DI
- B502BSB65350 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B502BSB65350 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Carcinoembryonic antigen (CEA) 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 CEA, Polyclonal, RPab 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-B502BSB65350 | 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 07f81358-e39e-4b42-90cd-962dfbe9938f 61 fields · synced Jun 18, 2026
- FDA UDI f156552b-3665-4265-b6ff-6d1c9fb91b40 34 fields · synced May 30, 2026