Duns Number:019410187
Device Description: Urine Drug Screen Card for detection of 12 drugs, Amphetamine, Barbiturate, Benzodiazepine Urine Drug Screen Card for detection of 12 drugs, Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, Phencyclidine and Tricyclic Antidepressants, CLIA Waived
Catalog Number
IS12-DX
Brand Name
Alere iScreen Dx
Version/Model Number
IS12-DX
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
K022355
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
aa0bda0b-ea87-49c7-b86a-69f22682da18
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
September 19, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 122 |
| U | Unclassified | 1 |