Duns Number:021192653
Device Description: AS-708 Anaerobic Catalase Reagent - 15% Hydrogen Peroxide is used to determine if an organ AS-708 Anaerobic Catalase Reagent - 15% Hydrogen Peroxide is used to determine if an organism is producing catalase and/or peroxidase. 30 mL fill volume. 30 mL dropping bottle. 1 bottler per pack.
Catalog Number
AS-708
Brand Name
Anaerobic Catalase Reagent - 15% Hydrogen Peroxide
Version/Model Number
AS-708
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
bb5cfd42-bf82-4f5f-9169-63c39e4525e8
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 |