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Triage 94613

by Quidel Cardiovascular Inc.

Ref 94613Model Triage

Triage 94613 is a device classified as IVD General (EU), Class I (US) made by Quidel Cardiovascular Inc., registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI B-30014613338116) and listed in FDA GUDID since 24 Jul 2019 (UDI-DI 30014613338116), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613338116 Basic UDI-DI 30014613338116UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613338116 UDI-DI Date24 Jul 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-30014613338116 registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 30014613338116 listed 24 Jul 2019 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 30014613338116
  2. Registered EUDAMED B-30014613338116

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  • Withdrawn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
Triage TOX Drug Screen Control 1 EUDAMED
Triage GUDID
Generic name
Multiple drugs of abuse IVD, control
Device name
TOX Drug Screen Control 1
Model / Ref / Catalog
94613, Triage
Primary DI / UDI-DI
30014613338116
Basic UDI-DI
B-30014613338116
FDA product code
DIF
EMDN code
W0102152009 Controls for narcotics / toxicology
GMDN term
Multiple drugs of abuse IVD, control
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.3280
EU registration type
Legacy device (under a directive)
EU market of registration
Türkiye
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: Multiple drugs of abuse IVD, control

Similar devices in this category

Other devices filed under CONTROLS FOR NARCOTICS / TOXICOLOGY.

Other devices from Quidel Cardiovascular Inc.

See all devices from Quidel Cardiovascular Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Near-patient testing
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)