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FACSCanto

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
FACSCanto FDA UDI
Generic Name
Laboratory analyser operation system software IVD FDA UDI
Device Name
BD FACSCanto™ Clinical Software v4.0.1 FDA UDI
Model / Reference
664119 FDA UDI
Description
BD FACSCanto™ Clinical Software v4.0.1 FDA UDI

Identifiers

Catalog Number
664119 FDA UDI
Primary DI / UDI-DI
00382906641199 FDA UDI
FDA Product Code
GKZ FDA UDI
GMDN Term
Laboratory analyser operation system software IVD 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

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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory analyser operation system software IVD

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

Similar devices

Also classified as Laboratory analyser operation system software IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Becton Dickinson And Company

Sources (1)

  • FDA UDI e6d4b1f4-9ca1-45dc-bbef-83f54004a629 36 fields · synced May 31, 2026