Duns Number:039981550
Device Description: All Purpose Quad Plate (Eosine Methylene Blue (EMB) Agar / Mannitol Salt Agar (MSA) / Myco All Purpose Quad Plate (Eosine Methylene Blue (EMB) Agar / Mannitol Salt Agar (MSA) / Mycobiotic Agar / Blood Agar, 5%), 15x100mm Quadplate, 5ml/section. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens. Hardy Diagnostics Mannitol Salt Agar (MSA) is recommended for use as a selective and differential medium for the isolation of pathogenic staphylococci. Hardy Diagnostics Mycobiotic Agar is recommended for use in the isolation of pathogenic fungi from clinical specimens.
Catalog Number
J79
Brand Name
N/A
Version/Model Number
J79
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
8a48c14f-8949-49a9-bb08-2a5e9bcfcff6
Public Version Date
June 01, 2020
Public Version Number
1
DI Record Publish Date
May 24, 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 |