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i-STAT 06P17-11

by Abbott Point of Care Inc.

Ref 06P17-11

i-STAT 06P17-11 is a device classified as IVD General (EU), Class I (US) made by Abbott Point of Care Inc., registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI B-00054749001156) and listed in FDA GUDID since 23 Jun 2023 (UDI-DI 00054749001156), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00054749001156 Basic UDI-DI 00054749001156UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00054749001156 UDI-DI Date23 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00054749001156 registered 2 Sep 2026 Active
  • FDA GUDID UDI-DI 00054749001156 listed 23 Jun 2023 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 00054749001156
  2. Registered EUDAMED B-00054749001156

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  • Withdrawn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
i-STAT
Generic name
Troponin I IVD, control
Device name
i-STAT cTnI Control Level 3
Model / Ref / Catalog
06P17-11
Primary DI / UDI-DI
00054749001156
Basic UDI-DI
B-00054749001156
FDA product code
JJY
EMDN code
W0102152004 Cardiac marker controls
GMDN term
Troponin I 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
Germany
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: Troponin I IVD, control

Similar devices in this category

Other devices filed under CARDIAC MARKER CONTROLS.

Other devices from Abbott Point of Care Inc.

See all devices from Abbott Point of Care Inc. →

Properties

  • Single use
  • Contains latex
  • Contains human tissues or cells
  • Near-patient testing
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)