Duns Number:039981550
Device Description: V Agar / Starch Agar with Bromcresol Purple, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostic V Agar / Starch Agar with Bromcresol Purple, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics Starch Agar with Bromcresol Purple is recommended for use in the differentiation of Gardnerella vaginalis from genitourinary specimens. Hardy Diagnostics V Agar is an enriched media used for the isolation and differentiation of Gardnerella vaginalis.
Catalog Number
J181
Brand Name
N/A
Version/Model Number
J181
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2022
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
JSG
Product Code Name
Culture Media, Non-Selective And Non-Differential
Public Device Record Key
d9e19025-1d33-403e-b6f5-f26e20b1d4f1
Public Version Date
April 01, 2022
Public Version Number
2
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 |