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Triage 98013XR

by Quidel Cardiovascular Inc.

Ref 98013XRModel Triage

Triage 98013XR 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-30014613337010), cleared under FDA 510(k) K000230 on 29 Feb 2000 and listed in FDA GUDID since 1 Nov 2018 (UDI-DI 30014613337010), active as of 24 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 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K000230

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-30014613337010 Basic UDI-DI 30014613337010UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number30014613337010 UDI-DI Date1 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK000230 Date29 Feb 2000DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-30014613337010 registered 13 Oct 2026 Active
  • FDA 510(k) K000230 decided 29 Feb 2000 Active
  • FDA GUDID UDI-DI 30014613337010 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) K000230
  2. Listed FDA GUDID 30014613337010
  3. Registered EUDAMED B-30014613337010

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  • Withdrawn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 Control 1 EUDAMED
Triage GUDID
Generic name
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control
Device name
BNP Control 1
Model / Ref / Catalog
98013XR, Triage
Primary DI / UDI-DI
30014613337010
Basic UDI-DI
B-30014613337010
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

Cleared under the same submission (K000230)

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)