Duns Number:039981550
Device Description: CatScreen™, rapid test for Moraxella (Branhamella) catarrhalis (M. cat.)using butyrate est CatScreen™, rapid test for Moraxella (Branhamella) catarrhalis (M. cat.)using butyrate esterase, 25 disks tests per packageRapid test for the detection of the enzyme butyrate esterase in bacteria isolated on culture media for the presumptive identification of Branhamella (Moraxella) catarrhalis. Performs a butyrate test within 5 minutes. Simply moisten disk, inoculate with organism, then wait for the development of a red color.
Catalog Number
Z110
Brand Name
CatScreen™
Version/Model Number
Z110
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
K960996,K960996
Product Code
JTO
Product Code Name
Discs, Strips And Reagents, Microorganism Differentiation
Public Device Record Key
d8b019a8-c33f-49a5-8b00-987af34ee78f
Public Version Date
July 17, 2020
Public Version Number
1
DI Record Publish Date
July 09, 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 |