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Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems LK016.CB.A

by The Binding Site Group

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05051700021104 UDI-DI Date2 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2030-2021 FDA Class II initiated 20 May 2021

    The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems
Generic Name
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Model / Reference
LK016.CB.A
Primary DI / UDI-DI
05051700021104
510(k) Number
FDA Product Code
DFH
GMDN Term
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry
Device Class
Class II
Regulation Number
866.5550
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K070900)

Other devices from The Binding Site Group

See all devices from The Binding Site Group →

Properties

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

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No