Duns Number:605213545
Device Description: A non-selective medium used for isolation, cultivation and enumeration of non-fastidious a A non-selective medium used for isolation, cultivation and enumeration of non-fastidious and fastidious microorganisms. The device is designed to interface directly with standard methods for bacterial testing of water samples using the Membrane Filter (MF) Technique.
Catalog Number
21-443-001
Brand Name
InTray® TSA
Version/Model Number
1443
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
32b70c88-7938-4f90-b22c-93d5a12bd56f
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 12, 2018
Package DI Number
B08814434
Quantity per Package
20
Contains DI Package
B08814430
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box