BD MAX™ Cdiff (US) - Kit BD MAX Cdiff USA - BECTON, DICKINSON AND COMPANY

Duns Number:122561087

Device Description: Kit BD MAX Cdiff USA

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More Product Details

Catalog Number

443418

Brand Name

BD MAX™ Cdiff (US)

Version/Model Number

443418

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

K130470

Product Code Details

Product Code

OZN

Product Code Name

C.Difficile toxin gene amplification assay

Device Record Status

Public Device Record Key

08d13a45-7801-4172-a97b-3d30944605b6

Public Version Date

August 03, 2022

Public Version Number

4

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