Duns Number:039981550
Device Description: Coliscreen, 15x45mm tube, .5ml fill, 20 tubes per boxFor the presumptive identification of Coliscreen, 15x45mm tube, .5ml fill, 20 tubes per boxFor the presumptive identification of Escherichia coli using the Indole and Glucuronidase tests.
Catalog Number
Z204
Brand Name
N/A
Version/Model Number
Z204
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
K961191,K961191
Product Code
JTO
Product Code Name
Discs, Strips And Reagents, Microorganism Differentiation
Public Device Record Key
af8d1712-b96c-456d-8b91-a6764150e533
Public Version Date
July 01, 2020
Public Version Number
1
DI Record Publish Date
June 23, 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 |