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Triage 98814EU

by Quidel Cardiovascular Inc.

Ref 98814EUModel Triage

Triage 98814EU is a device classified as IVD General (EU), Class I (US) made by Quidel Cardiovascular Inc., registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI B-30014613337072) and listed in FDA GUDID since 7 Nov 2018 (UDI-DI 30014613337072), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613337072 Basic UDI-DI 30014613337072UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613337072 UDI-DI Date7 Nov 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-30014613337072 registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI 30014613337072 listed 7 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 30014613337072
  2. Registered EUDAMED B-30014613337072

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  • Withdrawn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 PLGF Control 2 EUDAMED
Triage GUDID
Generic name
Placental growth factor (PLGF) IVD, control
Device name
PLGF Control 2
Model / Ref / Catalog
98814EU, Triage
Primary DI / UDI-DI
30014613337072
Basic UDI-DI
B-30014613337072
FDA product code
JJX
EMDN code
W0102152002 Hormone controls
GMDN term
Placental growth factor (PLGF) 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
Northern Ireland
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: Placental growth factor (PLGF) IVD, control

Similar devices in this category

Other devices filed under HORMONE 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
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (15, all answered No)