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Sofia 20253

by Quidel Corp.

Sofia 20253 is a Class I device made by Quidel Corp., cleared under FDA 510(k) K123793 on 17 Jun 2013 and listed in FDA GUDID since 10 Nov 2018 (UDI-DI 30014613202530), 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) K123793

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 Number30014613202530 UDI-DI Date10 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123793 Date17 Jun 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123793 decided 17 Jun 2013 Active
  • FDA GUDID UDI-DI 30014613202530 listed 10 Nov 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123793
  2. Listed FDA GUDID 30014613202530

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  • Withdrawn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
Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
20253
Primary DI / UDI-DI
30014613202530
510(k) Number
FDA product code
GTY
GMDN term
Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay
Device class
Class I
Regulation number
866.3740
GUDID distribution status
In Commercial Distribution

Related devices

Category: Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay

Cleared under the same submission (K123793)

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)