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LABScan3D™ LABSCNXS4

by One Lambda, Inc.

LABScan3D LABSCNXS4 is a HLA class I & II antigen tissue typing IVD (FDA Class II; FDA product code NSU, Instrumentation For Clinical Multiplex Test Systems) made by One Lambda, Inc., listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00814695022588), registry data as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00814695022588 UDI-DI Date31 Aug 2016ListedStatusListed 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  • Withdrawn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
LABScan3D™
Generic name
HLA class I & II antigen tissue typing IVD, kit, multiplex
Catalogue number
LABSCNXS4
Primary DI / UDI-DI
00814695022588
FDA product code
NSU
GMDN term
HLA class I & II antigen tissue typing IVD, kit, multiplex
Device class
Class II
Regulation number
862.2570
GUDID distribution status
In Commercial Distribution

Related devices

Category: HLA class I & II antigen tissue typing IVD, kit, multiplex

Similar devices

Also classified as HLA class I & II antigen tissue typing IVD, kit, multiplex.

Similar devices in this category

Other devices filed under HLA class I & II antigen tissue typing IVD, kit, multiplex.

Other devices from One Lambda, Inc.

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Properties

  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)