Skip to content

QuickVue 20125

by Quidel Corp.

Ref 20125Model QuickVue Dipstick Strep A 25-Test Kit

QuickVue 20125 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-30014613201250), cleared under FDA 510(k) K011097 on 8 May 2001 and listed in FDA GUDID since 10 Nov 2018 (UDI-DI 30014613201250), active as of 7 Nov 2026. 2 FDA recalls are 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

2 ongoing

This device is named in the recall

Documents

None, self-declared

Class I: no certifier involved

510(k) K011097

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-30014613201250 Basic UDI-DI 30014613201250UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613201250 UDI-DI Date10 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK011097 Date8 May 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30014613201250 registered 4 Nov 2026 Active
  • FDA 510(k) K011097 decided 8 May 2001 Active
  • FDA GUDID UDI-DI 30014613201250 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

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2169-2026 FDA Class II initiated 6 Apr 2026

    Product has the potential for false positive results

    • Ongoing Z-2545-2025 FDA Class II initiated 17 Jun 2025

    Dipstick strep A test has potential for false positive results.

Timeline

5 dated events

  1. Cleared FDA 510(k) K011097
  2. Listed FDA GUDID 30014613201250
  3. Recall initiated FDA recalls Z-2545-2025
  4. Recall initiated FDA recalls Z-2169-2026
  5. Registered EUDAMED B-30014613201250

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  • Withdrawn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
QuickVue Dipstick Strep A 25-Test Kit EUDAMED
QuickVue GUDID
Generic name
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
20125, QuickVue Dipstick Strep A 25-Test Kit
Primary DI / UDI-DI
30014613201250
Basic UDI-DI
B-30014613201250
510(k) Number
FDA product code
GTY
EMDN code
W0105011101 Streptococcal direct antigen detection
GMDN term
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
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
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: Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Cleared under the same submission (K011097)

Similar devices in this category

Other devices filed under STREPTOCOCCAL DIRECT ANTIGEN 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
  • Expiration date
Other properties (18, all answered No)