Duns Number:401656868
Device Description: A dip slide culture method for the detection of bacteriuria and the presumptive identific A dip slide culture method for the detection of bacteriuria and the presumptive identification of uropathogens.
Catalog Number
1003
Brand Name
Uricult® CLED+Polymyxin / MacConkey
Version/Model Number
68017
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
7c04e36f-0e0b-4b3e-8606-9adfce617dcd
Public Version Date
March 02, 2020
Public Version Number
5
DI Record Publish Date
May 13, 2016
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |