Duns Number:039981550
Device Description: Tryptic Soy Broth (TSB) with 6.5% Sodium Chloride, 15x103mm Tube, 5ml. Hardy Diagnostics T Tryptic Soy Broth (TSB) with 6.5% Sodium Chloride, 15x103mm Tube, 5ml. Hardy Diagnostics Tryptic Soy Broth (TSB) with 6.5% NaCl is a growth medium recommended for the differentiation of enterococci from the group D streptococci. This medium is also useful as an enrichment step for increasing sensitivity in the detection of MRSA in high risk patients.
Catalog Number
K126
Brand Name
N/A
Version/Model Number
K126
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
JSD
Product Code Name
Culture Media, Selective Broth
Public Device Record Key
f324e98b-6920-47b6-912b-51f5396f170d
Public Version Date
June 01, 2020
Public Version Number
1
DI Record Publish Date
May 24, 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 |