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Sofia 2 20405

by Quidel Corp.

Sofia 2 20405 is a Class II device made by Quidel Corp., cleared under FDA 510(k) K233688 on 13 Dec 2023, granted FDA De Novo DEN220039 on 8 Mar 2023 and listed in FDA GUDID since 28 Mar 2023 (UDI-DI 30014613339755), active as of 23 Oct 2026.

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

510(k) De Novo

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK233688 Date13 Dec 2023DecidedStatusActive
United StatesGUDID listing Number30014613339755 UDI-DI Date28 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG from GUDID De Novo granted · Post-NSE NumberDEN220039 Date8 Mar 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K233688 decided 13 Dec 2023 Active
  • FDA De Novo DEN220039 decided 8 Mar 2023 Active
  • FDA GUDID UDI-DI 30014613339755 listed 28 Mar 2023 Listed

Timeline

3 dated events

  1. Granted FDA De Novo DEN220039
  2. Listed FDA GUDID 30014613339755
  3. Cleared FDA 510(k) K233688

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA De Novo, FDA 510(k) Active

Specification

GUDID

Trade name
Sofia 2
Generic name
SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
20405
Primary DI / UDI-DI
30014613339755
510(k) Number
De Novo Number
FDA product code
QVF
GMDN term
SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay
Device class
Class II
Regulation number
866.3982
GUDID distribution status
In Commercial Distribution

Related devices

Category: SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay

Similar devices

Other devices filed under FDA product code QVF (Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings).

Other devices from Quidel Corp.

See all devices from Quidel Corp. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)