Duns Number:137417965
Device Description: A qualitative one-step immunochromatographic test for the detection of Cocaine and/or meta A qualitative one-step immunochromatographic test for the detection of Cocaine and/or metabolites in human urine.
Catalog Number
-
Brand Name
VERDICT®-II
Version/Model Number
601585
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2021
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
K003687,K982211,K003687,K982211
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
8c0b3a3f-d804-42bc-82b4-b786623fcc2f
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
10690286000114
Quantity per Package
25
Contains DI Package
00690286000117
Package Discontinue Date
April 30, 2021
Package Status
Not in Commercial Distribution
Package Type
Kit Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |