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Triage 98015XR

by Quidel Cardiovascular Inc.

Ref 98015XRModel Triage

Triage 98015XR 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-30014613337034), cleared under FDA 510(k) K000231 on 2 Mar 2000 and listed in FDA GUDID since 1 Nov 2018 (UDI-DI 30014613337034), active as of 23 Oct 2026.

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 found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K000231

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-30014613337034 Basic UDI-DI 30014613337034UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613337034 UDI-DI Date1 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK000231 Date2 Mar 2000DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30014613337034 registered 13 Oct 2026 Active
  • FDA 510(k) K000231 decided 2 Mar 2000 Active
  • FDA GUDID UDI-DI 30014613337034 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

3 dated events

  1. Cleared FDA 510(k) K000231
  2. Listed FDA GUDID 30014613337034
  3. Registered EUDAMED B-30014613337034

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  • Withdrawn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 BNP Calibration Verification EUDAMED
Triage GUDID
Generic name
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
Model / Ref / Catalog
98015XR, Triage
Primary DI / UDI-DI
30014613337034
Basic UDI-DI
B-30014613337034
510(k) Number
FDA product code
JJX
EMDN code
W0102152004 Cardiac marker controls
GMDN term
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide 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: B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

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)