Skip to content

Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems

by The Binding Site Group Ltd

Ref LK016.CB

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number5051700LK016.CBXD Basic UDI-DI 05051700012096UDI-DIDate20 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05051700012096 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems EUDAMED
Freelite® Human Kappa Free Kit for use on the Roche cobas® systems GUDID
Generic Name
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Model / Reference
LK016.CB
Primary DI / UDI-DI
05051700012096
Basic UDI-DI
5051700LK016.CBXD
510(k) Number
FDA Product Code
DFH
EMDN Code
W0102010109 Kappa and lambda chain
GMDN Term
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Device Class
Class C 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 C
GUDID
Class II

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
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • 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
  • New Device: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No