Duns Number:039981550
Device Description: Todd Hewitt Broth, 15x103mm Tube, 1ml. Hardy Diagnostics Todd Hewitt Broth is recommended Todd Hewitt Broth, 15x103mm Tube, 1ml. Hardy Diagnostics Todd Hewitt Broth is recommended for the production of antigenic streptococcal hemolysin and the cultivation of streptococci prior to serological grouping. It is also recommended for the cultivation of beta-hemolytic streptococci, pneumococci, and other fastidious organisms.
Catalog Number
K112
Brand Name
N/A
Version/Model Number
K112
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
7adef76b-7ca9-4488-acee-9672c8509949
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 |