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PAXgene® Blood RNA Kit Version 2

by Preanalytix GmbH

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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
United StatesGUDID listing GUDID Number04053727000149 UDI-DI Date26 Feb 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
PAXgene® Blood RNA Kit
Generic Name
Nucleic acid extraction/isolation kit IVD
Model / Ref / Catalog
Version 2, 762164
Primary DI / UDI-DI
04053727000149
510(k) Number
FDA Product Code
NTW
GMDN Term
Nucleic acid extraction/isolation kit IVD
Device Class
Class II
Regulation Number
866.4070
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Cleared under the same submission (K082150)

Other devices from Preanalytix GmbH

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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