Duns Number:021192653
Device Description: AS-701 Indole reagent is intended for use in the Spot-Indole Test for detection of indole AS-701 Indole reagent is intended for use in the Spot-Indole Test for detection of indole production by anaerobic bacteria. p-Dimethylaminocinnamaldehyde. 30 mL fill volume. 30 mL dropping bottle. 1 bottle per pack.
Catalog Number
AS-701
Brand Name
Indole Reagent - p-Dimethylaminocinnamaldehyde
Version/Model Number
AS-701
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
-
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
4d573126-8621-44d9-aa81-e5fde6855035
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 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 | 148 |