Duns Number:039981550
Device Description: Indole, Kovac's Reagent, for tube test, 15mlP-dimethylaminobenzaldehyde, to test indole pr Indole, Kovac's Reagent, for tube test, 15mlP-dimethylaminobenzaldehyde, to test indole production in indole broth or for biochemical strip/cupule methods. Positive indole reactions with Kovac's will turn pink to red. Does not require a xylene or chloroform extraction as with Ehrlich's Reagent. Kovac's Reagent is not for rapid spot indole on filter paper. For the rapid spot test, see Cat. no. K65, which is DMACA (cinnamaldehyde).
Catalog Number
Z67
Brand Name
N/A
Version/Model Number
Z67
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
JTO
Product Code Name
Discs, Strips And Reagents, Microorganism Differentiation
Public Device Record Key
6ac71275-5751-49c2-84b7-8dcd9dea3a02
Public Version Date
June 24, 2020
Public Version Number
1
DI Record Publish Date
June 16, 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 |