Duns Number:039981550
Device Description: Catalase Reagent, hydrogen peroxide 3%Hydrogen peroxide 3%, (H2O2), catalase positive orga Catalase Reagent, hydrogen peroxide 3%Hydrogen peroxide 3%, (H2O2), catalase positive organisms (such as Staphylococcus) will evolve gas bubbles in the presence of H2O2. Useful in the presumptive identification and differentiation of many bacteria. Beta-hemolytic organisms, such as Streptococcus species (catalase-negative), Staphylococcus species (catalase-positive), and Listeria species (catalase-positive) can be differentiated by their catalase reaction.
Catalog Number
Z62
Brand Name
N/A
Version/Model Number
Z62
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
01ba4eab-b5fa-426a-b900-c1e8c93068ff
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 |