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BD FACSuite

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
BD FACSuite FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
BD FACSuite™ Clinical Flow Cytometry Software v1.3 FDA UDI
Model / Reference
663003 FDA UDI
Description
BD FACSuite™ Clinical Flow Cytometry Software v1.3 FDA UDI

Identifiers

Catalog Number
663003 FDA UDI
Primary DI / UDI-DI
00382906630032 FDA UDI
FDA Product Code
OYE FDA UDI
GMDN Term
Laboratory instrument/analyser application 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 instrument/analyser application software IVD

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

Similar devices

Also classified as Laboratory instrument/analyser application 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 61c62dd5-c892-44d8-8530-c66a2f5f5e70 36 fields · synced May 29, 2026