← Back to catalogue
Tinto Mycobacterium tuberculosis, Polyclonal, RPab
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref BSB 2993
by Bio SB Inc
Identity
- Trade Name
- Tinto Mycobacterium tuberculosis, Polyclonal, RPab EUDAMEDTinto Mycobacterium tuberculosis RPab FDA UDI
- Generic Name
- Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, reagent FDA UDI
- Device Name
- Tinto Mycobacterium tuberculosis, Polyclonal, RPab EUDAMEDMycobacterium tuberculosis is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5 FDA UDI
- Model / Reference
- BSB 2993 EUDAMEDPredilute, 7 ml FDA UDI
- Description
- Mycobacterium tuberculosis is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5 FDA UDI
Identifiers
- Catalog Number
- BSB 2993 FDA UDI
- Primary DI / UDI-DI
- B502BSB29930 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B502BSB29930 EUDAMED
- FDA Product Code
- MVU FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, reagent 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
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 Mycobacterium tuberculosis, Polyclonal, RPab by Bio Sb, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-B502BSB29930 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio SB Inc
- EUDAMED SRN
- US-MF-000036462
- Authorised Representative
- QAdvis EAR AB SE-AR-000001599
Sources (2)
- EUDAMED 252ecbb3-4d05-4929-8557-9f431f6295ca 61 fields · synced Sep 17, 2026
- FDA UDI d5b1798d-5904-4c08-80a7-949eedf3ad8c 34 fields · synced May 27, 2026