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Ortho™ Anti-A1 Lectin Dolichos biflorus Blood Grouping Lectin 6141138

by Alba Bioscience Limited

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060242472909 UDI-DI Date14 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Ortho™ Anti-A1 Lectin Dolichos biflorus Blood Grouping Lectin
Generic Name
Anti-A1 red blood cell grouping IVD, lectin
Model / Reference
6141138
Primary DI / UDI-DI
05060242472909
FDA Product Code
KSI
GMDN Term
Anti-A1 red blood cell grouping IVD, lectin
Device Class
Class II
Regulation Number
864.9550
GUDID distribution status
In Commercial Distribution

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Properties

  • Contains Latex
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No