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FIX&PERM® Sample Kit Cell Fixation and Permeabilization kit

by Vector Laboratories, Inc.

Ref GAS-002M-CE/IVD

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number08600156845FIXPERMCEIVDRQ Basic UDI-DI 00860015684547UDI-DIDate7 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Fix&Perm®
Model / Reference
GAS-002M-CE/IVD
Primary DI / UDI-DI
00860015684547
Basic UDI-DI
08600156845FIXPERMCEIVDRQ
Direct Marketing DI
00860015684547
EMDN Code
W0103080599 Auxiliary & supplemental reagents for flow cytometry - other
Device Class
Class A
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000057003
Authorised representative
QbD RepS BV BE-AR-000000040

From the manufacturer

Manufacturer's product page: ImmPRESS HRP Kits

Other devices from Vector Laboratories, Inc.

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No