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i-STAT 06P17-16

by Abbott Point of Care Inc.

Ref 06P17-16

i-STAT 06P17-16 is a device classified as IVD General (EU), Class II (US) made by Abbott Point of Care Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-00054749001248), cleared under FDA 510(k) K120900 on 31 May 2013 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00054749001248), active as of 7 Nov 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 7 Nov 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K120900

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00054749001248 Basic UDI-DI 00054749001248UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00054749001248 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK120900 Date31 May 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00054749001248 registered 26 Oct 2026 Active
  • FDA 510(k) K120900 decided 31 May 2013 Active
  • FDA GUDID UDI-DI 00054749001248 listed 9 Sep 2016 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) K120900
  2. Listed FDA GUDID 00054749001248
  3. Registered EUDAMED B-00054749001248

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  • Withdrawn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
i-STAT ACT Control Level 2 EUDAMED
i-STAT GUDID
Generic name
Activated clotting time (ACT) IVD, control
Model / Ref / Catalog
06P17-16
Primary DI / UDI-DI
00054749001248
Basic UDI-DI
B-00054749001248
510(k) Number
FDA product code
GGN
EMDN code
W010302080501 Hemostasis controls rt & poc
GMDN term
Activated clotting time (ACT) IVD, control
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
864.5425
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 II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Activated clotting time (ACT) IVD, control

Cleared under the same submission (K120900)

Similar devices in this category

Other devices filed under HEMOSTASIS CONTROLS RT & POC.

Other devices from Abbott Point of Care Inc.

See all devices from Abbott Point of Care Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Near-patient testing
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)