Duns Number:119214195
Device Description: A rapid, one step screening test for the simultaneous, qualitative detection of multiple d A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.
Catalog Number
-
Brand Name
Detector Drug Cup
Version/Model Number
HCDOAV-3104
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
DIO
Product Code Name
Enzyme immunoassay, cocaine and cocaine metabolites
Public Device Record Key
965b215a-c629-4842-9506-3c67989e831e
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
May 21, 2018
Package DI Number
20722355002570
Quantity per Package
4
Contains DI Package
10722355002573
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case of 4
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |