Duns Number:039981550
Device Description: Agar Deep, 1.5%, (Water Agar), 16x125mm pour tube, 9ml Deep, order by the package of 20Har Agar Deep, 1.5%, (Water Agar), 16x125mm pour tube, 9ml Deep, order by the package of 20Hardy Diagnostics Agar, 1.5% (Water Agar) is used in the Kirby-Bauer alternative agar-overlay method of inoculation for antimicrobial disk diffusion susceptibility testing and for microbiological procedures that require an additive-free solid medium, such as in performing colony counts, testing antimicrobial disk potency, or in performing the modified fungal slide culture method.
Catalog Number
Q01
Brand Name
N/A
Version/Model Number
Q01
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
JSG
Product Code Name
Culture Media, Non-Selective And Non-Differential
Public Device Record Key
1364dcd9-650e-4565-90c7-4f5276ddff03
Public Version Date
June 12, 2020
Public Version Number
1
DI Record Publish Date
June 04, 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 |