Duns Number:039981550
Device Description: OxiStrips™, Oxidase test, 25 paper strips per packageOxiStrips™ Oxidase Strips are ready t OxiStrips™, Oxidase test, 25 paper strips per packageOxiStrips™ Oxidase Strips are ready to use test strips with a convenient plastic handle so the user can avoid skin contact with the reaction area and are used for the detection of cytochrome oxidase activity in bacteria
Catalog Number
Z93
Brand Name
OxiStrips™
Version/Model Number
Z93
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
01c4b340-8c61-4bf8-9673-5d9169f27dc1
Public Version Date
August 20, 2020
Public Version Number
1
DI Record Publish Date
August 12, 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 |