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Tinto Cytokeratin Cocktail AE1 and AE3, AE1 and AE3, MMab

by Bio SB Inc 3 variants

Ref BSB 5429

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-B502BSB54290 Basic UDI-DI B502BSB54290UDI-DIDate6 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberB502BSB54290 UDI-DI Date1 Jun 2020ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Tinto Cytokeratin Cocktail AE1 and AE3, AE1 and AE3, MMab EUDAMED
Tinto Cytokeratin Cocktail AE1 & AE3, MMab GUDID
Generic Name
Cytokeratin IVD, antibody
Model / Ref / Catalog
BSB 5429, Predilute, 7 ml
Primary DI / UDI-DI
B502BSB54290
Basic UDI-DI
B-B502BSB54290
FDA Product Code
NJT
EMDN Code
W01030709 Primary antisera for immunohistology
GMDN Term
Cytokeratin IVD, antibody
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
864.1860
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BSB 5429
GUDID
Predilute, 7 ml
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

Other properties (20)

  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No