Henry Schein

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name: Henry Schein FDA UDI
Generic Name: Total haemoglobin (totHb) IVD, reagent FDA UDI
Device Name: Microcuvettes FDA UDI
Model / Reference: 5701312 FDA UDI
Description: Microcuvettes FDA UDI

Identifiers

Catalog Number: 5701312 FDA UDI
Primary DI / UDI-DI: 20304040103795 FDA UDI
FDA Product Code: GKR FDA UDI
GMDN Term: Total haemoglobin (totHb) IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5620 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Total haemoglobin (totHb) IVD, reagent

Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Teco Diagnostics Hemoglobin Reagent Set — TECO DIAGNOSTICS · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Henry Schein, Inc.

Sources (1)

FDA UDI 43feeb9b-df60-4aa8-9bda-b05254e9adf6 35 fields · synced Jun 8, 2026