BD Trucount

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name: BD Trucount FDA UDI
Generic Name: Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI
Device Name: BD Trucount™ Tubes FDA UDI
Model / Reference: 340334 FDA UDI
Description: BD Trucount™ Tubes FDA UDI

Identifiers

Catalog Number: 340334 FDA UDI
Primary DI / UDI-DI: 00382903403349 FDA UDI
FDA Product Code: GKZ FDA UDI
OYE FDA UDI
GMDN Term: Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5220 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)White blood cell count IVD, reagent

BD Trucount by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Becton Dickinson And Company

Sources (1)

FDA UDI 7d1748fc-ccbf-42b9-acdb-2bf36420bc65 36 fields · synced Jun 8, 2026