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Sofia 20299R

by Quidel Corp.

Sofia 20299R is a Class I device made by Quidel Corp., cleared under FDA 510(k) K162911 on 22 Feb 2017 and listed in FDA GUDID since 21 Oct 2020 (UDI-DI 30014613336648), 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) K162911

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 Number30014613336648 UDI-DI Date21 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162911 Date22 Feb 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162911 decided 22 Feb 2017 Active
  • FDA GUDID UDI-DI 30014613336648 listed 21 Oct 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-1183-2018 FDA Class II initiated 15 Dec 2017 on shared 510(k) K162911

    The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote possibility that incorrect qualitative test results for patient samples near the assay cutoff may be reported.

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) K162911
  2. Recall initiated FDA recalls Z-1183-2018
  3. Listed FDA GUDID 30014613336648

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  • Withdrawn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
20299R
Primary DI / UDI-DI
30014613336648
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 (K162911)

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)