Duns Number:039981550
Device Description: PDA with Fildes and Nafcillin, 15x100mm Plate, 19ml. Hardy Diagnostics Peptic Digest Agar PDA with Fildes and Nafcillin, 15x100mm Plate, 19ml. Hardy Diagnostics Peptic Digest Agar (PDA) with Fildes and Nafcillin is an enrichment medium recommended for the selective isolation of Haemophilus species.
Catalog Number
G141
Brand Name
N/A
Version/Model Number
G141
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
9253518c-785d-46e4-9e8a-d34e19614e9e
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 |