Catalog Number

215359

Brand Name

BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA

Version/Model Number

215359

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

K092767,K092767,K092767

Product Code

JSO

Product Code Name

CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR

Public Device Record Key

63ed861b-540e-428b-b360-d27c5edee9d4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 16, 2016

Package DI Number

30382902153598

Quantity per Package

2

Contains DI Package

10382902153594

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack