← Back to catalogue

FACSCount

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
FACSCount FDA UDI
Generic Name
Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow) FDA UDI
Device Name
BD FACSCount Reagent Kit 50 Tests IVD FDA UDI
Model / Reference
340167 FDA UDI
Description
BD FACSCount Reagent Kit 50 Tests IVD FDA UDI

Identifiers

Catalog Number
340167 FDA UDI
Primary DI / UDI-DI
00382903401673 FDA UDI
FDA Product Code
GKL FDA UDI
GKZ 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
864.5200 FDA UDI
864.5220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

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

Similar devices

Also classified as Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Becton Dickinson And Company

Sources (1)

  • FDA UDI 276cb55f-51a2-4966-bd19-79270f77103f 36 fields · synced May 30, 2026