Duns Number:039981550
Device Description: Peptone Yeast Extract Glucose Broth, 16x125mm Tube with Hungate Septum Cap, 9ml. Hardy Dia Peptone Yeast Extract Glucose Broth, 16x125mm Tube with Hungate Septum Cap, 9ml. Hardy Diagnostics AnaeroGRO™ Peptone Yeast Extract Glucose Broth (PYG) is an enriched, non-selective medium recommended for the cultivation and biochemical identification of obligately anaerobic microorganisms. This medium is also suitable for the growth of anaerobic bacteria to be identified by gas liquid chromatography (GLC) analysis as outlined by the CDC.
Catalog Number
AG24H
Brand Name
AnaeroGRO
Version/Model Number
AG24H
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
JSC
Product Code Name
Culture Media, General Nutrient Broth
Public Device Record Key
de8ae432-d459-464b-9faf-84b55639d973
Public Version Date
May 21, 2020
Public Version Number
1
DI Record Publish Date
May 13, 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 |