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Sofia 20260

by Quidel Corp.

Ref 20260Model Sofia RSV 25T

Sofia 20260 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-30014613202608), cleared under FDA 510(k) K130398 on 13 Aug 2013 and listed in FDA GUDID since 10 Nov 2018 (UDI-DI 30014613202608), active as of 7 Nov 2026.

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 found

in data synced 7 Nov 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K130398

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-30014613202608 Basic UDI-DI 30014613202608UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613202608 UDI-DI Date10 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK130398 Date13 Aug 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30014613202608 registered 4 Nov 2026 Active
  • FDA 510(k) K130398 decided 13 Aug 2013 Active
  • FDA GUDID UDI-DI 30014613202608 listed 10 Nov 2018 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K130398
  2. Listed FDA GUDID 30014613202608
  3. Registered EUDAMED B-30014613202608

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  • Withdrawn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 RSV 25T EUDAMED
Sofia GUDID
Generic name
Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
20260, Sofia RSV 25T
Primary DI / UDI-DI
30014613202608
Basic UDI-DI
B-30014613202608
510(k) Number
FDA product code
GQG
EMDN code
W0105040605 Respiratory syncytial virus (rsv)
GMDN term
Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
866.3480
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: Respiratory syncytial virus (RSV) antigen IVD, kit, fluorescent immunoassay

Cleared under the same submission (K130398)

Similar devices in this category

Other devices filed under OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION.

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)