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FLC Control Level 2 5113

by Sebia

FLC Control Level 2 5113 is a Class II device made by Sebia, listed in FDA GUDID since 31 Mar 2023 (UDI-DI 03607360051139), registry data as of 12 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03607360051139 UDI-DI Date31 Mar 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
FLC Control Level 2
Generic name
Kappa/lambda light chain immunoglobulin IVD, control
Model / Ref / Catalog
5113
Primary DI / UDI-DI
03607360051139
FDA product code
DFH, DEH
GMDN term
Kappa/lambda light chain immunoglobulin IVD, control
Device class
Class II
Regulation number
866.5550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Kappa/lambda light chain immunoglobulin IVD, control

Similar devices in this category

Other devices filed under Kappa/lambda light chain immunoglobulin IVD, control.

Other devices from Sebia

See all devices from Sebia →

Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)