Catalog Number

442953

Brand Name

BD MAX™ MRSA

Version/Model Number

442953

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 27, 2021

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

K120138

Product Code

NQX

Product Code Name

SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN

Public Device Record Key

07360350-88a0-4d53-9b8d-9e8d51f930be

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

July 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-