Duns Number:039981550
Device Description: Mannitol Salt Agar (MSA) with Oxacillin, 15x100mm Plate, 18ml. Hardy Diagnostics Mannitol Mannitol Salt Agar (MSA) with Oxacillin, 15x100mm Plate, 18ml. Hardy Diagnostics Mannitol Salt Agar (MSA) with Oxacillin is used as a primary screening medium for the simultaneous detection and differentiation of methicillin resistant Staphylococcus spp. (MRS). It can be used as a cost effective screening method for MRSA.
Catalog Number
G97
Brand Name
N/A
Version/Model Number
G97
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
bd271f71-a60d-4331-98ac-30c2d7bc46da
Public Version Date
May 28, 2020
Public Version Number
1
DI Record Publish Date
May 20, 2020
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 |