Duns Number:276816717
Device Description: Manual reagent for catalase test. API®strips give accurate identifications based on extens Manual reagent for catalase test. API®strips give accurate identifications based on extensive databases and are standardized, easy-to-use test systems.
Catalog Number
-
Brand Name
API® ID-ASE
Version/Model Number
API® ID-ASE
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)
Yes
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
8b661a60-e65a-4aa9-90df-763ced591d95
Public Version Date
July 29, 2019
Public Version Number
1
DI Record Publish Date
July 19, 2019
Package DI Number
03573026092009
Quantity per Package
2
Contains DI Package
03573026584139
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |