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Henry Schein 5701312

by Henry Schein, Inc.

Henry Schein 5701312 is a Class II device made by Henry Schein, Inc., listed in FDA GUDID since 11 Jan 2019 (UDI-DI 20304040103795), 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 Number20304040103795 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  • Withdrawn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, reagent
Model / Ref / Catalog
5701312
Primary DI / UDI-DI
20304040103795
FDA product code
GKR
GMDN term
Total haemoglobin (totHb) IVD, reagent
Device class
Class II
Regulation number
864.5620
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total 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

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)