Duns Number:039981550
Device Description: MRSA / VRE BIPLATE(Sect. 1: MH with 4% NaCl and Oxacillin 6mcg/ml; Sect II: BHI Agar with MRSA / VRE BIPLATE(Sect. 1: MH with 4% NaCl and Oxacillin 6mcg/ml; Sect II: BHI Agar with Vancomycin 6mcg/ml). For the detection of Methicillin Resistant Staphylococcus aureus and Vancomycin Resistant Enterococci.
Catalog Number
J112
Brand Name
NA
Version/Model Number
J112
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 17, 2020
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
JSO
Product Code Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Public Device Record Key
304cb67d-28e0-4524-8e90-a2e5dc7babc0
Public Version Date
June 18, 2020
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |