HemoCue® WBC Microcuvettes

FDA UDI

Class II (US FDA UDI)

by Hemocue, Inc.

Identity

Trade Name: HemoCue® WBC Microcuvettes FDA UDI
Generic Name: Haematological cell analyser IVD FDA UDI
Device Name: HemoCue WBC Microcuvettes 4x40 vial FDA UDI
Model / Reference: 113003 FDA UDI
Description: HemoCue WBC Microcuvettes 4x40 vial FDA UDI

Identifiers

Catalog Number: 113003 FDA UDI
Primary DI / UDI-DI: 17311091130034 FDA UDI
510(k) Number: K071652 FDA UDI
FDA Product Code: GKL FDA UDI
GMDN Term: Haematological cell analyser IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5200 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: Haematological cell analyser IVD

HemoCue® WBC Microcuvettes by Hemocue, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K071652 also covers:

HemoCue® WBC Analyzer — Hemocue, Inc.

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: Hemocue, Inc.

Sources (1)

FDA UDI 5e4f08b4-668e-4669-9c61-c5be02afa6ab 36 fields · synced Jun 6, 2026