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Triage 55071

by Quidel Cardiovascular Inc.

Ref 55071Model Triage

Triage 55071 is a device classified as IVD General (EU), Class A (EU), Class II (US) made by Quidel Cardiovascular Inc., registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI B-30014613337164) and listed in FDA GUDID since 1 Nov 2018 (UDI-DI 30014613337164), active as of 7 Nov 2026.

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

CE IVDR 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/IVDR EUDAMED NumberB-30014613337164 Basic UDI-DI 30014613337164UDI-DIDate13 Oct 2026RegisteredStatusActive
European UnionCE/IVDD EUDAMED NumberB-30014613337164 Basic UDI-DI 30014613337164UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613337164 UDI-DI Date1 Nov 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-30014613337164 registered 13 Oct 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 30014613337164 listed 1 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 30014613337164
  2. Registered EUDAMED B-30014613337164

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Triage MeterPro EUDAMED
Triage GUDID
Generic name
Fluorescent immunoassay analyser IVD, point-of-care
Device name
MeterPro
Model / Ref / Catalog
55071, Triage
Primary DI / UDI-DI
30014613337164
Basic UDI-DI
B-30014613337164, 0014613Mepq0TMwyah4D2dYV8
FDA product code
JHX, KHO, MMI, DDR
EMDN code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
GMDN term
Fluorescent immunoassay analyser IVD, point-of-care
Device class
Class IVD General EUDAMED
Class A EUDAMED
Class II GUDID
Regulation number
862.1215, 862.2560, 866.5680
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Türkiye
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General and Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes.

Related devices

Category: Fluorescent immunoassay analyser IVD, point-of-care

Similar devices in this category

Other devices filed under AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h).

Other devices from Quidel Cardiovascular Inc.

See all devices from Quidel Cardiovascular Inc. →

Properties

  • Single use
  • IVD kit
  • Near-patient testing
  • Professional testing
  • IVD instrument
  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (17, all answered No)