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QuickVue In-Line 00345

by Quidel Corp.

QuickVue In-Line 00345 is a Class I device made by Quidel Corp., cleared under FDA 510(k) K945080 on 10 Feb 1995 and listed in FDA GUDID since 21 Mar 2019 (UDI-DI 30014613003458), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K945080

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 Number30014613003458 UDI-DI Date21 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK945080 Date10 Feb 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K945080 decided 10 Feb 1995 Active
  • FDA GUDID UDI-DI 30014613003458 listed 21 Mar 2019 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1598-2022 FDA Class II initiated 25 May 2022

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Timeline

3 dated events

  1. Cleared FDA 510(k) K945080
  2. Listed FDA GUDID 30014613003458
  3. Recall initiated FDA recalls Z-1598-2022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
QuickVue In-Line
Generic name
Beta-haemolytic Group A Streptococcus antigen IVD, control
Model / Ref / Catalog
00345
Primary DI / UDI-DI
30014613003458
510(k) Number
FDA product code
GTY
GMDN term
Beta-haemolytic Group A Streptococcus antigen IVD, control
Device class
Class I
Regulation number
866.3740
GUDID distribution status
In Commercial Distribution

Related devices

Category: Beta-haemolytic Group A Streptococcus antigen IVD, control

Similar devices

Other devices filed under FDA product code GTY (ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.).

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)