Duns Number:806524968
Device Description: his kit tests for 12 Drugs including Prescription Drugs: 7 Illicit Drugs Marijua his kit tests for 12 Drugs including Prescription Drugs: 7 Illicit Drugs Marijuana, Cocaine, Opiates (Heroin), Methamphetamine, Ecstasy, Amphetamine, Phencyclidine (PCP) 5 Prescription Drugs Tricyclic Antidepressants, Barbiturates, Benzodiazepines, Methadone, Oxycodone
Catalog Number
-
Brand Name
DrugConfirm™ 12 Panel Instant Drug Test
Version/Model Number
03-5202
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)
-
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
a6e3ccb1-3a6f-4509-890f-11d46d1b0a5a
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 06, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |