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Dynabeads™ HLA Cell Prep™ II 21903

by Thermo Fisher Scientific Baltics Uab

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10190302006835 UDI-DI Date3 Jul 2018ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDD EUDAMED Number— Date—StatusActive

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  • Withdrawn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
Dynabeads™ HLA Cell Prep™ II
Generic Name
B lymphocyte magnetic separation reagent IVD
Model / Reference
21903
Primary DI / UDI-DI
10190302006835
FDA Product Code
JCF
GMDN Term
B lymphocyte magnetic separation reagent IVD
Device Class
Class I
Regulation Number
864.8500
GUDID distribution status
In Commercial Distribution

Related devices

Category: B lymphocyte magnetic separation reagent IVD

Other devices from Thermo Fisher Scientific Baltics Uab

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No