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QuickVue One-Step hCG Urine Test

by Quidel Corp.

Ref 20109Model QuickVue hCG Urine Test

QuickVue One-Step hCG Urine Test (20109) is a device classified as IVD General (EU), Class II (US) made by Quidel Corp., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-30014613201090), cleared under FDA 510(k) K020799 on 17 May 2002 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 30014613201090), 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) K020799

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-30014613201090 Basic UDI-DI 30014613201090UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613201090 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK020799 Date17 May 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30014613201090 registered 4 Nov 2026 Active
  • FDA 510(k) K020799 decided 17 May 2002 Active
  • FDA GUDID UDI-DI 30014613201090 listed 15 Sep 2016 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-1457-2011 FDA Unclassified (pre-2012) initiated 23 Nov 2010

    The recall was initiated after Quidel Corporation determined that a small number of QuickVue One-Step hCG Urine kits have been incorrectly packaged with QuickVue H. pylori gll cassettes inside the kit boxes. These foil pouches and test cassettes are clearly labeled as H. pylori. Nevertheless, there is a risk that customers may overlook this labeling.

Timeline

4 dated events

  1. Cleared FDA 510(k) K020799
  2. Recall initiated FDA recalls Z-1457-2011
  3. Listed FDA GUDID 30014613201090
  4. Registered EUDAMED B-30014613201090

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 hCG Urine Test EUDAMED
QuickVue GUDID
Generic name
Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
QuickVue hCG Urine Test, 20109, One-Step hCG Urine Test
Primary DI / UDI-DI
30014613201090
Basic UDI-DI
B-30014613201090
510(k) Number
FDA product code
JHI
EMDN code
W0102160302 Hcg - rt & poc
GMDN term
Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1155
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
QuickVue hCG Urine Test
20109
GUDID
One-Step hCG Urine Test
Device classEUDAMED
Class IVD General
GUDID
Class II

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

Related devices

Category: Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical

Similar devices in this category

Other devices filed under HCG - 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)