COULTER TruColor Wright- Giemsa Stain

FDA UDI

Class I (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name: COULTER TruColor Wright- Giemsa Stain FDA UDI
Generic Name: Biological stain IVD FDA UDI
Device Name: COULTER TruColor Wright-Giemsa Stain FDA UDI
Model / Reference: 7547178 FDA UDI
Description: COULTER TruColor Wright-Giemsa Stain FDA UDI

Identifiers

Catalog Number: 7547178 FDA UDI
Primary DI / UDI-DI: 15099590250713 FDA UDI
FDA Product Code: KQC FDA UDI
GMDN Term: Biological stain IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.1850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Biological stain IVD

COULTER TruColor Wright- Giemsa Stain by Beckman Coulter, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Hematek® Stain Pak - Wright-Giemsa Stain — Siemens Healthcare Diagnostics · Class I
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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 I	Pending data

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Manufacturer

Manufacturer: Beckman Coulter, Inc.

Sources (1)

FDA UDI 76405632-eb79-4226-8b79-40ac802f2d49 35 fields · synced Jun 8, 2026