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Lambda Antigen Tray™ - Mixed Class I LATM120

by One Lambda, Inc.

Lambda Antigen Tray - Mixed Class I LATM120 is a HLA class I & II antibody screening IVD (FDA unclassified; FDA product code MZI, Test,Qualitative,For Hla,Non-Diagnostic) made by One Lambda, Inc., listed in FDA GUDID since 11 Aug 2016 (UDI-DI 00812117012506), 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 Number00812117012506 UDI-DI Date11 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  • Withdrawn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
Lambda Antigen Tray™ - Mixed Class I
Generic name
HLA class I & II antibody screening IVD, kit, multiplex
Catalogue number
LATM120
Primary DI / UDI-DI
00812117012506
FDA product code
MZI
GMDN term
HLA class I & II antibody screening IVD, kit, multiplex
Device class
U
GUDID distribution status
In Commercial Distribution

Related devices

Category: HLA class I & II antibody screening IVD, kit, multiplex

Similar devices

Other devices filed under FDA product code MZI (Test,Qualitative,For Hla,Non-Diagnostic).

Other devices from One Lambda, Inc.

See all devices from One Lambda, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)