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Optilite® IgG4 Kit

by The Binding Site Group Ltd

Ref LK009.OPT

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150526↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number5051700LK009.OPT55 Basic UDI-DI 05051700017183UDI-DIDate7 Aug 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK150526 Date30 May 2015IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-1089-2017 FDA Class III initiated 23 Dec 2016 on shared 510(k) K150526

    A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/IVDR Active

Specification

EUDAMED · 510(k)

Model / Reference
LK009.OPT
Primary DI / UDI-DI
05051700017183
Basic UDI-DI
5051700LK009.OPT55
EMDN Code
W0102010106 Immunoglobulin g subclass reagents
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
UK-MF-000036707
Authorised representative
The Binding Site Ireland Limited IE-AR-000034426

Other devices from The Binding Site Group Ltd

See all devices from The Binding Site Group Ltd →

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No