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Sofia 20218

by Quidel Corp.

Ref 20218Model Sofia Influenza A+B FIA

Sofia 20218 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-30014613202189), cleared under FDA 510(k) K112177 on 24 Oct 2011 and listed in FDA GUDID since 10 Nov 2018 (UDI-DI 30014613202189), 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

None ongoing

1 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K112177

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-30014613202189 Basic UDI-DI 30014613202189UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613202189 UDI-DI Date10 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK112177 Date24 Oct 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30014613202189 registered 4 Nov 2026 Active
  • FDA 510(k) K112177 decided 24 Oct 2011 Active
  • FDA GUDID UDI-DI 30014613202189 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 · FDA

    • Terminated Z-0819-2013 FDA Class II initiated 3 Dec 2012

    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.

Timeline

4 dated events

  1. Cleared FDA 510(k) K112177
  2. Recall initiated FDA recalls Z-0819-2013
  3. Listed FDA GUDID 30014613202189
  4. Registered EUDAMED B-30014613202189

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  • Withdrawn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 Influenza A+B FIA EUDAMED
Sofia GUDID
Generic name
Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
20218, Sofia Influenza A+B FIA
Primary DI / UDI-DI
30014613202189
Basic UDI-DI
B-30014613202189
510(k) Number
FDA product code
GNX
EMDN code
W0105040604 Influenza & para influenza
GMDN term
Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
866.3330
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
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: Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

Cleared under the same submission (K112177)

Similar devices in this category

Other devices filed under INFLUENZA & PARA INFLUENZA.

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
  • Serial number
  • Expiration date
Other properties (16, all answered No)