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QuickVue In-Line 00343

by Quidel Corp.

Ref 00343Model QuickVue In-Line Strep A Test

QuickVue In-Line 00343 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-30014613003434) and listed in FDA GUDID since 10 Nov 2018 (UDI-DI 30014613003434), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613003434 Basic UDI-DI 30014613003434UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613003434 UDI-DI Date10 Nov 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-30014613003434 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 30014613003434 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

2 dated events

  1. Listed FDA GUDID 30014613003434
  2. Registered EUDAMED B-30014613003434

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
QuickVue In-Line Strep A Test EUDAMED
QuickVue In-Line GUDID
Generic name
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
00343, QuickVue In-Line Strep A Test
Primary DI / UDI-DI
30014613003434
Basic UDI-DI
B-30014613003434
FDA product code
GTZ
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

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
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)