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Triage High Sensitivity Troponin I Control 1

by Quidel Cardiovascular Inc.

Ref 97613EUModel Triage

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-30014613338079 Basic UDI-DI 30014613338079UDI-DIDate13 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
High Sensitivity Troponin I Control 1
Model / Reference
Triage, 97613EU
Primary DI / UDI-DI
30014613338079
Basic UDI-DI
B-30014613338079
EMDN Code
W0102152004 Cardiac marker controls
Device Class
Class IVD General
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
US-MF-000025154
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No