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Sofia 20276

by Quidel Corp.

Ref 20276Model Sofia Strep A+ FIA 25T

Sofia 20276 is a device classified as IVD General (EU), Class I (US) made by Quidel Corp., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-30014613202769), cleared under FDA 510(k) K141775 on 16 Dec 2014 and listed in FDA GUDID since 10 Nov 2018 (UDI-DI 30014613202769), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None, self-declared

Class I: no certifier involved

510(k) K141775

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613202769 Basic UDI-DI 30014613202769UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613202769 UDI-DI Date10 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Dual Track NumberK141775 Date16 Dec 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30014613202769 registered 4 Nov 2026 Active
  • FDA 510(k) K141775 decided 16 Dec 2014 Active
  • FDA GUDID UDI-DI 30014613202769 listed 10 Nov 2018 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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

4 dated events

  1. Cleared FDA 510(k) K141775
  2. Listed FDA GUDID 30014613202769
  3. Recall initiated FDA recalls Z-1598-2022
  4. Registered EUDAMED B-30014613202769

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Sofia Strep A+ FIA 25T EUDAMED
Sofia GUDID
Generic name
Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
20276, Sofia Strep A+ FIA 25T
Primary DI / UDI-DI
30014613202769
Basic UDI-DI
B-30014613202769
510(k) Number
FDA product code
GTY
EMDN code
W0105090103 Strep. a - rt & poc
GMDN term
Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
866.3740
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

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

Cleared under the same submission (K141775)

Similar devices in this category

Other devices filed under STREP. A - RT & POC.

Other devices from Quidel Corp.

See all devices from Quidel Corp. →

Properties

  • Single use
  • Contains animal tissues or cells
  • IVD kit
  • Near-patient testing
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)