BD MAX™ GBS - Kit BD Max GBS - BECTON, DICKINSON AND COMPANY

Duns Number:122561087

Device Description: Kit BD Max GBS

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More Product Details

Catalog Number

441772

Brand Name

BD MAX™ GBS

Version/Model Number

441772

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

Yes

Prescription Use (Rx)

Yes

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

NJR

Product Code Name

Nucleic acid amplification assay system, group b streptococcus, direct specimen test

Device Record Status

Public Device Record Key

46a3eea7-fcae-445e-911b-378fef9123ed

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

May 19, 2016

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