FACS - BD FACS™ Sample Prep Assistant III Software - BECTON, DICKINSON AND COMPANY

Duns Number:024230633

Device Description: BD FACS™ Sample Prep Assistant III Software

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

657765

Brand Name

FACS

Version/Model Number

657765

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PER

Product Code Name

Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis

Device Record Status

Public Device Record Key

f56ec9b9-6752-4bd7-911a-69d3055aac54

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

February 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BECTON, DICKINSON AND COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 611
2 A medical device with a moderate to high risk that requires special controls. 614
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4