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Henry Schein 5701314

by Henry Schein, Inc.

Henry Schein 5701314 is a Class II device made by Henry Schein, Inc., listed in FDA GUDID since 11 Jan 2019 (UDI-DI 00304040103814), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00304040103814 UDI-DI Date11 Jan 2019ListedStatusListed 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  • Withdrawn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
Henry Schein
Generic name
Total haemoglobin (totHb) IVD, kit, spectrophotometry
Model / Ref / Catalog
5701314
Primary DI / UDI-DI
00304040103814
FDA product code
GKR
GMDN term
Total haemoglobin (totHb) IVD, kit, spectrophotometry
Device class
Class II
Regulation number
864.5620
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total haemoglobin (totHb) IVD, controlTotal haemoglobin (totHb) IVD, kit, spectrophotometryTotal haemoglobin (totHb) IVD, reagent

Similar devices

Other devices filed under FDA product code GKR (SYSTEM, HEMOGLOBIN, AUTOMATED).

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

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