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Facs

FDA UDI

Class I (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name
FACS FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
BD FACS™ Sample Prep Assistant III Software FDA UDI
Model / Reference
657765 FDA UDI
Description
BD FACS™ Sample Prep Assistant III Software FDA UDI

Identifiers

Catalog Number
657765 FDA UDI
Primary DI / UDI-DI
00382906577658 FDA UDI
FDA Product Code
PER FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2750 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

No

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

Yes

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

Facs by Becton Dickinson And Company — Class I — 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

Sources (1)

  • FDA UDI f56ec9b9-6752-4bd7-911a-69d3055aac54 36 fields · synced May 30, 2026