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ThromboTek PSe 90-480

by r2 Diagnostics Inc.

Ref 90-480

ThromboTek PSe 90-480 is a device classified as IVD General (EU), Class II (US) made by r2 Diagnostics Inc., registered in EUDAMED on 20 May 2026 (Basic UDI-DI B-00859394006095), cleared under FDA 510(k) K082631 on 17 Dec 2008 and listed in FDA GUDID since 15 Nov 2016 (UDI-DI 00859394006095), active as of 22 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 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K082631

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00859394006095 Basic UDI-DI 00859394006095UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00859394006095 UDI-DI Date15 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK082631 Date17 Dec 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00859394006095 registered 20 May 2026 Active
  • FDA 510(k) K082631 decided 17 Dec 2008 Active
  • FDA GUDID UDI-DI 00859394006095 listed 15 Nov 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) K082631
  2. Listed FDA GUDID 00859394006095
  3. Registered EUDAMED B-00859394006095

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  • Withdrawn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
ThromboTek PSe
Generic name
Protein S IVD, kit, clotting
Model / Ref / Catalog
90-480
Primary DI / UDI-DI
00859394006095
Basic UDI-DI
B-00859394006095
510(k) Number
FDA product code
GGP
EMDN code
W0103020608 Protein s activity
GMDN term
Protein S IVD, kit, clotting
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
864.7290
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
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.

From the manufacturer

Manufacturer's product page: ThromboTek PSe

Related devices

Category: Protein S IVD, kit, clotting

Similar devices in this category

Other devices filed under COAGULATION INHIBITORS/THROMBOPHILIA MARKERS.

Other devices from r2 Diagnostics Inc.

See all devices from r2 Diagnostics Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)