Catalog Number

442963

Brand Name

BD MAX™ Enteric Bacterial Panel

Version/Model Number

442963

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K140111

Product Code

OOI

Product Code Name

real time Nucleic acid amplification system

Public Device Record Key

fbf614f6-b0cc-48a2-b28b-0ae298b0cb1f

Public Version Date

November 24, 2021

Public Version Number

4

DI Record Publish Date

October 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-