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QuickVue One-Step hCG Combo Test

by Quidel Corp.

Ref 20110Model QuickVue hCG Combo Test

QuickVue One-Step hCG Combo Test (20110) 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-30014613201106), cleared under FDA 510(k) K020801 on 17 May 2002 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI 30014613201106), 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) K020801

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-30014613201106 Basic UDI-DI 30014613201106UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613201106 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK020801 Date17 May 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30014613201106 registered 4 Nov 2026 Active
  • FDA 510(k) K020801 decided 17 May 2002 Active
  • FDA GUDID UDI-DI 30014613201106 listed 15 Sep 2016 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) K020801
  2. Listed FDA GUDID 30014613201106
  3. Registered EUDAMED B-30014613201106

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  • Withdrawn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 Combo Test EUDAMED
QuickVue GUDID
Generic name
Human chorionic gonadotropin beta-subunit IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
QuickVue hCG Combo Test, 20110, One-Step hCG Combo Test
Primary DI / UDI-DI
30014613201106
Basic UDI-DI
B-30014613201106
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 Combo Test
20110
GUDID
One-Step hCG Combo 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)