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Triage 88754

by Quidel Cardiovascular Inc.

Ref 88754Model Triage

Triage 88754 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-30014613337119), cleared under FDA 510(k) K072892 on 7 Dec 2007 and listed in FDA GUDID since 1 Nov 2018 (UDI-DI 30014613337119), active as of 24 Oct 2026. 5 FDA recalls are 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

5 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K072892

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613337119 Basic UDI-DI 30014613337119UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613337119 UDI-DI Date1 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK072892 Date7 Dec 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30014613337119 registered 13 Oct 2026 Active
  • FDA 510(k) K072892 decided 7 Dec 2007 Active
  • FDA GUDID UDI-DI 30014613337119 listed 1 Nov 2018 Listed

Certificates

0 certificates · EUDAMED

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

Recalls

5 recalls · FDA

    • Terminated Z-3054-2020 FDA Class II initiated 28 Jul 2020

    Product was shipped with refrigeration (ice) instead of frozen (dry ice).

    • Terminated Z-0588-2017 FDA Class II initiated 12 Oct 2016

    Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.

  • 3 recalls, same reason

    • Terminated Z-1790-2010 FDA Unclassified (pre-2012) initiated 6 Feb 2009
    • Terminated Z-1788-2010 FDA Unclassified (pre-2012) initiated 6 Feb 2009
    • Terminated Z-1789-2010 FDA Unclassified (pre-2012) initiated 6 Feb 2009

    Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.

Timeline

8 dated events

  1. Cleared FDA 510(k) K072892
  2. Recall initiated FDA recalls Z-1790-2010
  3. Recall initiated FDA recalls Z-1788-2010
  4. Recall initiated FDA recalls Z-1789-2010
  5. Recall initiated FDA recalls Z-0588-2017
  6. Listed FDA GUDID 30014613337119
  7. Recall initiated FDA recalls Z-3054-2020
  8. Registered EUDAMED B-30014613337119

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
Triage Total 5 Control 2 EUDAMED
Triage GUDID
Generic name
Multiple cardiac marker IVD, control
Device name
Total 5 Control 2
Model / Ref / Catalog
88754, Triage
Primary DI / UDI-DI
30014613337119
Basic UDI-DI
B-30014613337119
510(k) Number
FDA product code
JJY
EMDN code
W0102152004 Cardiac marker controls
GMDN term
Multiple cardiac marker IVD, control
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1660
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 cardiac marker IVD, control

Cleared under the same submission (K072892)

Similar devices in this category

Other devices filed under CARDIAC MARKER CONTROLS.

Other devices from Quidel Cardiovascular Inc.

See all devices from Quidel Cardiovascular Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Near-patient testing
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (14, all answered No)