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QuickVue 0B006

by Quidel Corp.

QuickVue 0B006 is a Class I device made by Quidel Corp., cleared under FDA 510(k) K946276 on 19 May 1995 and listed in FDA GUDID since 10 Nov 2018 (UDI-DI 30014613200062), 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) K946276

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 Number30014613200062 UDI-DI Date10 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK946276 Date19 May 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K946276 decided 19 May 1995 Active
  • FDA GUDID UDI-DI 30014613200062 listed 10 Nov 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K946276
  2. Listed FDA GUDID 30014613200062

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  • Withdrawn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
Multiple Chlamydia species antigen IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
0B006
Primary DI / UDI-DI
30014613200062
510(k) Number
FDA product code
LJC
GMDN term
Multiple Chlamydia species antigen IVD, kit, rapid ICT, clinical
Device class
Class I
Regulation number
866.3120
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple Chlamydia species antigen IVD, kit, rapid ICT, clinical

Similar devices

Other devices filed under FDA product code LJC (ENZYME LINKED IMMUNOABSORBENT ASSAY, (CHLAMYDIAE GROUP)).

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)