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CMV Brite Turbo kit

by IQ Products BV Netherlands EUDAMEDGUDID

Ref VIR-CMV 110Model Kit Product code LINEMDN W0105040299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-08717953022301 Basic UDI-DIDate25 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08717953022301 UDI-DIDate19 Sep 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
CMV Brite Turbo kit EUDAMED
CMV Brite™ Turbo, CMV antigenemia detection kit GUDID
Generic Name
Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
Kit EUDAMED
VIR-CMV 110 EUDAMED
VIR-CMV110 BDC GUDID
Primary DI / UDI-DI
08717953022301
Basic UDI-DI
B-08717953022301
510(k) Number
FDA Product Code
LIN
EMDN Code
W0105040299 Cmv reagents - other
GMDN Term
Cytomegalovirus (CMV) antigen IVD, kit, fluorescent immunoassay
Device Class
Class IVD Annex II List B EUDAMED
Class II GUDID
Regulation Number
866.3175
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Kit
VIR-CMV 110
GUDID
VIR-CMV110 BDC
Device ClassEUDAMED
Class IVD Annex II List B
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000010812

From the manufacturer

Manufacturer's product page: CMV Brite™ Turbo Kit

Other devices from IQ Products BV

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Professional Testing
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
Other properties (18)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED de7cf20e-ab1b-4ca0-9472-bb1f3de2e34c 61 fields · synced 22 Oct 2026
  • FDA UDI bbd33614-45c5-4b3e-aed2-56d0094569e2 37 fields · synced 30 May 2026