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LTA Check Test Kit 107117

by Bio/Data Corporation

Ref 107117

LTA Check Test Kit 107117 is a device classified as Class A in the EU and Class I in the US made by Bio/Data Corporation, registered in EUDAMED on 27 May 2026 (Basic UDI-DI ++G0561071174F) and listed in FDA GUDID since 30 Aug 2023 (UDI-DI *+G0561071171/ $$0100365XXXXX/*), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number++G0561071174F Basic UDI-DI *+G0561071171/ $$0100365XXXXX/*UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number*+G0561071171/ $$0100365XXXXX/* UDI-DI Date30 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++G0561071174F registered 27 May 2026 Active
  • FDA GUDID UDI-DI *+G0561071171/ $$0100365XXXXX/* listed 30 Aug 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 *+G0561071171/ $$0100365XXXXX/*
  2. Registered EUDAMED ++G0561071174F

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
LTA Check Test Kit
Generic name
von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent
Device name
LTA Check Test Kit (Performance Monitoring)
Model / Ref / Catalog
107117
Primary DI / UDI-DI
*+G0561071171/ $$0100365XXXXX/* EUDAMED
G0561071170 GUDID
Basic UDI-DI
++G0561071174F
FDA product code
JJX
EMDN code
W0103010605, W01030199
GMDN term
von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
*+G0561071171/ $$0100365XXXXX/*
GUDID
G0561071170
Device classEUDAMED
Class A
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists *+G0561071171/ $$0100365XXXXX/*; FDA GUDID lists G0561071170), so their flags are not compared. Device class is stated on each registry's own scale: Class A 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: von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

Similar devices in this category

Other devices filed under HAEMATOLOGY TESTS - RT & POC.

Other devices from Bio/Data Corporation

See all devices from Bio/Data Corporation →

Properties

  • Single use
  • Contains human tissues or cells
  • Reagent
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)