Catalog Number

441637

Brand Name

BD GeneOhm™ MRSA ACP Assay (48 tests)

Version/Model Number

441637

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 12, 2018

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

-

Product Code

NQX

Product Code Name

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

Public Device Record Key

a181aa3e-1aea-4f26-9c92-ff82cc57f43a

Public Version Date

November 24, 2021

Public Version Number

4

DI Record Publish Date

August 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-