Duns Number:137417965
Device Description: A qualitative one-step immunochromatographic test for the detection of Benzodiazepines and A qualitative one-step immunochromatographic test for the detection of Benzodiazepines and/or metabolites in human urine.
Catalog Number
-
Brand Name
VERDICT®-II
Version/Model Number
601624
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2019
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
K002331,K010959,K002331,K010959
Product Code
JXM
Product Code Name
Enzyme Immunoassay, Benzodiazepine
Public Device Record Key
47a212b6-f3fe-45a3-9a1e-373ff6266deb
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
10690286000183
Quantity per Package
25
Contains DI Package
00690286000186
Package Discontinue Date
December 31, 2019
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 |