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QuickVue 20222

by Quidel Corp.

QuickVue 20222 is a Class I device made by Quidel Corp., cleared under FDA 510(k) K101918 on 24 Sep 2010 and listed in FDA GUDID since 10 Nov 2018 (UDI-DI 30014613202226), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K101918

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30014613202226 UDI-DI Date10 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK101918 Date24 Sep 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K101918 decided 24 Sep 2010 Active
  • FDA GUDID UDI-DI 30014613202226 listed 10 Nov 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K101918
  2. Listed FDA GUDID 30014613202226

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
QuickVue
Generic name
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
20222
Primary DI / UDI-DI
30014613202226
510(k) Number
FDA product code
GQG
GMDN term
Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Device class
Class I
Regulation number
866.3480
GUDID distribution status
In Commercial Distribution

Related devices

Category: Respiratory syncytial virus (RSV) 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)