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Tinto IFN-Alpha, BSB-158, MMab

by Bio SB Inc EUDAMEDGUDID

Active European Union

Ref BSB-3733-7

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-B502BSB373370 Basic UDI-DIDate6 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberB502BSB373370 UDI-DIDate18 Mar 2025ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Tinto IFN-Alpha, BSB-158, MMab EUDAMED
Tinto IFN-Alpha (BSB-158) GUDID
Generic Name
Interferon IVD, antibody
Model / Ref / Catalog
BSB-3733-7
Primary DI / UDI-DI
B502BSB373370
Basic UDI-DI
B-B502BSB373370
FDA Product Code
NJT
EMDN Code
W01030709 Primary antisera for immunohistology
GMDN Term
Interferon IVD, antibody
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
864.1860
Market of Registration
Sweden
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 7 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000036462
Authorised representative
QAdvis EAR AB SE-AR-000001599

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See all devices from Bio Sb, Inc. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • 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
  • Serial Number: No
  • Manufacturing Date: No