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D-100 12008984

by Bio-Rad Laboratories

D-100 12008984 is a Class I device made by Bio-Rad Laboratories, listed in FDA GUDID since 31 Jan 2023 (UDI-DI 03610522060696), 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 Number03610522060696 UDI-DI Date31 Jan 2023ListedStatusListed 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  • Withdrawn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
D-100
Generic name
Glycated haemoglobin (HbA1C) analyser IVD
Model / Ref / Catalog
12008984
Primary DI / UDI-DI
03610522060696
FDA product code
LDM
GMDN term
Glycated haemoglobin (HbA1C) analyser IVD
Device class
Class I
Regulation number
862.2260
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glycated haemoglobin (HbA1C) analyser IVD

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Premarket exempt
Other properties (14, all answered No)