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Sofia 20221

by Quidel Corp.

Sofia 20221 is a Class I device made by Quidel Corp., cleared under FDA 510(k) K112177 on 24 Oct 2011 and listed in FDA GUDID since 7 Mar 2019 (UDI-DI 30014613202219), 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 ongoing

1 closed

Documents

510(k) K112177

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 Number30014613202219 UDI-DI Date7 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK112177 Date24 Oct 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112177 decided 24 Oct 2011 Active
  • FDA GUDID UDI-DI 30014613202219 listed 7 Mar 2019 Listed

Recalls

1 recall · FDA

    • Terminated Z-0819-2013 FDA Class II initiated 3 Dec 2012 on shared 510(k) K112177

    Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K112177
  2. Recall initiated FDA recalls Z-0819-2013
  3. Listed FDA GUDID 30014613202219

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sofia
Generic name
Fluorescent immunoassay analyser IVD, point-of-care
Model / Ref / Catalog
20221
Primary DI / UDI-DI
30014613202219
510(k) Number
FDA product code
KHO
GMDN term
Fluorescent immunoassay analyser IVD, point-of-care
Device class
Class I
Regulation number
862.2560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fluorescent immunoassay analyser IVD, point-of-care

Cleared under the same submission (K112177)

Similar devices

Other devices filed under FDA product code KHO (FLUOROMETER, FOR CLINICAL USE).

Other devices from Quidel Corp.

See all devices from Quidel Corp. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)