Duns Number:039981550
Device Description: Egg Yolk Agar, Modified, 15x100mm Plate, 18ml. Hardy Diagnostics Egg Yolk Agar, Modified i Egg Yolk Agar, Modified, 15x100mm Plate, 18ml. Hardy Diagnostics Egg Yolk Agar, Modified is recommended for use as an enriched, non-selective and differential medium used in the cultivation, isolation and differentiation of Clostridium spp. and other anaerobic bacilli.
Catalog Number
G215
Brand Name
N/A
Version/Model Number
G215
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
JSH
Product Code Name
Culture Media, Non-Selective And Differential
Public Device Record Key
97a6c1bf-42ff-49e0-a4b2-a6793501b195
Public Version Date
May 26, 2020
Public Version Number
1
DI Record Publish Date
May 18, 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 |