Skip to content

Fibrotek 70-410

by r2 Diagnostics Inc.

Ref 70-410

Fibrotek 70-410 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-00859394006040), cleared under FDA 510(k) K042919 on 29 Nov 2004 and listed in FDA GUDID since 15 Nov 2016 (UDI-DI 00859394006040), 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) K042919

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-00859394006040 Basic UDI-DI 00859394006040UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00859394006040 UDI-DI Date15 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK042919 Date29 Nov 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00859394006040 registered 20 May 2026 Active
  • FDA 510(k) K042919 decided 29 Nov 2004 Active
  • FDA GUDID UDI-DI 00859394006040 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) K042919
  2. Listed FDA GUDID 00859394006040
  3. Registered EUDAMED B-00859394006040

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  • Withdrawn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
FibroTek Fibrinogen kit EUDAMED
Fibrotek GUDID
Generic name
Fibrinogen assay (factor I) IVD, kit, clotting
Model / Ref / Catalog
70-410
Primary DI / UDI-DI
00859394006040
Basic UDI-DI
B-00859394006040
510(k) Number
FDA product code
KQJ, GIS
EMDN code
W0103020701 Calibration plasma for haemostasis
GMDN term
Fibrinogen assay (factor I) IVD, kit, clotting
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
864.7340
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.

Related devices

Category: Fibrinogen assay (factor I) IVD, kit, clotting

Similar devices in this category

Other devices filed under CALIBRATION PLASMA FOR HAEMOSTASIS.

Other devices from r2 Diagnostics Inc.

See all devices from r2 Diagnostics Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)