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Class II Complement - 5 ml CDR-5

by One Lambda, Inc.

Class II Complement - 5 ml CDR-5 is a HLA class I & II antigen tissue typing 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 00812117014326), 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 Number00812117014326 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  • Withdrawn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
Class II Complement - 5 ml
Generic name
HLA class I & II antigen tissue typing IVD, kit, multiplex
Catalogue number
CDR-5
Primary DI / UDI-DI
00812117014326
FDA product code
MZI
GMDN term
HLA class I & II antigen tissue typing IVD, kit, multiplex
Device class
U
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.

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)