Duns Number:039981550
Device Description: Nocardia Hydrolysis Kit for Actinomycetes, 18ml, (Total of 20 tubes) 20x125mm tubes of 4 d Nocardia Hydrolysis Kit for Actinomycetes, 18ml, (Total of 20 tubes) 20x125mm tubes of 4 different media types (5 each of Casein, Xanthine, Hypoxanthine, and Tyrosine Agars, in 20x125mm tubes, deep)(Nocardia Hydrolysis Kit) For use in determining the hydrolysis reaction on casein, xanthine, hypoxanthine, and tyrosine by Nocardia, Actinomycetales, Actinomadura, and Streptomyces spp. Box contains 5 tubes of each media. 20 tubes total.Contains:Casein Agar, Deep 18ml (5) 00819398022941Xanthine Agar, Deep 18ml (5) 00819398028462Hypoxathine Agar, Deep 18ml (5) 00819398028479Tyrosine Agar, Deep 18ml (5) 00819398028486
Catalog Number
Z604
Brand Name
N/A
Version/Model Number
Z604
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
8419c63e-d647-4d6f-ad03-fcd6ed9b574f
Public Version Date
August 17, 2020
Public Version Number
1
DI Record Publish Date
August 07, 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 |