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Tinto Prolactin, PRL02, MMab
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref BSB 5890
by Bio SB Inc
Identity
- Trade Name
- Tinto Prolactin, PRL02, MMab EUDAMEDTinto Prolactin MMab FDA UDI
- Generic Name
- Prolactin IVD, antibody FDA UDI
- Device Name
- Tinto Prolactin, PRL02, MMab EUDAMEDProlactin is a purified immunoglobulin fraction of mouse antiserum that is filter sterilized and diluted in buffer pH 7.5 FDA UDI
- Model / Reference
- BSB 5890 EUDAMEDPredilute, 7 ml FDA UDI
- Description
- Prolactin is a purified immunoglobulin fraction of mouse antiserum that is filter sterilized and diluted in buffer pH 7.5 FDA UDI
Identifiers
- Catalog Number
- BSB 5890 FDA UDI
- Primary DI / UDI-DI
- B502BSB58900 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B502BSB58900 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Prolactin 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
Yes
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 Prolactin, PRL02, MMab 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-B502BSB58900 | 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 b8a70b91-18dd-4829-a66a-9269775cc7f0 61 fields · synced Jun 18, 2026
- FDA UDI ad73f1b1-eb56-4c02-aec0-0af75aab8f5f 34 fields · synced May 30, 2026