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QuickVue 00317

by Quidel Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Overview

Explore the QkVue Flu Bulk 25T, a rapid immunochromatographic test for influenza A/B virus antigen detection in clinical specimens. Learn about its features, indications, and usage guidelines.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30014613003175 UDI-DI Date21 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
QuickVue
Generic name
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
00317
Primary DI / UDI-DI
30014613003175
FDA product code
GNX
GMDN term
Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Device class
Class I
Regulation number
866.3330
GUDID distribution status
In Commercial Distribution

Related devices

Category: Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Similar devices in this category

Other devices filed under Influenza A/B virus antigen IVD, kit, rapid ICT, clinical.

Other devices from Quidel Corp.

See all devices from Quidel Corp. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)