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Sickle-Heme GLD-250

by Great Lakes Diagnostics, Inc.

Sickle-Heme GLD-250 is a Class II device made by Great Lakes Diagnostics, Inc., listed in FDA GUDID since 13 Dec 2021 (UDI-DI 00860003629918), 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 Number00860003629918 UDI-DI Date13 Dec 2021ListedStatusListed 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  • Withdrawn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
Sickle-Heme
Generic name
Haemoglobin S (HbS) IVD, reagent
Model / Ref / Catalog
GLD-250
Primary DI / UDI-DI
00860003629918
FDA product code
GHM
GMDN term
Haemoglobin S (HbS) IVD, reagent
Device class
Class II
Regulation number
864.7825
GUDID distribution status
In Commercial Distribution

Related devices

Category: Haemoglobin S (HbS) IVD, reagent

Similar devices

Other devices filed under FDA product code GHM (Test, Sickle Cell).

Other devices from Great Lakes Diagnostics, Inc.

Properties

  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)