Duns Number:039981550
Device Description: Blood Agar 5% / Group A Beta Strep Agar, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Bl Blood Agar 5% / Group A Beta Strep Agar, 15x100mm Biplate, 10ml/10ml. 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 Group A Beta Strep Agar is an enriched media for the selective isolation of group A streptococci (Streptococcus pyogenes).
Catalog Number
J92
Brand Name
N/A
Version/Model Number
J92
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
JSJ
Product Code Name
Culture Media, Selective And Non-Differential
Public Device Record Key
0a88f04d-d925-4f71-81d8-03e93d3cc8e1
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 |