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Freelite® Human Lambda Free Kit for use on the Siemens BN™II LK018.T

by The Binding Site Group

Ref LK018.T

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

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05051700006491 Basic UDI-DI 05051700006491UDI-DIDate30 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05051700006491 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Freelite® Human Lambda Free Kit (for use on the Siemens BN™II) EUDAMED
Freelite® Human Lambda Free Kit for use on the Siemens BN™II GUDID
Generic Name
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Model / Reference
LK018.T
Primary DI / UDI-DI
05051700006491
Basic UDI-DI
B-05051700006491
FDA Product Code
DEH
EMDN Code
W0102010109 Kappa and lambda chain
GMDN Term
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
866.5550
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

Other devices from The Binding Site Group

See all devices from The Binding Site Group →

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No