Duns Number:010551716
Device Description: (BZO/BAR)+(COC/THC)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+ MET1000 + OPI300 multiple drugs dipcar (BZO/BAR)+(COC/THC)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+ MET1000 + OPI300 multiple drugs dipcard
Catalog Number
IMD-12MO3
Brand Name
ImmuTest Drugs of Abuse Screen Card
Version/Model Number
IMD-12MO3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 20, 2018
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
K113046
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
0f7f0db4-98c6-4d5d-81f8-cd542ae62d3b
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
September 01, 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. | 131 |
| U | Unclassified | 1 |