Duns Number:010551716
Device Description: 9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, 9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
Catalog Number
IMCA-9CM5
Brand Name
ImmuTest Drugs of Abuse Cup
Version/Model Number
IMCA-9CM5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 09, 2020
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
41df7d53-ba81-4d4f-931c-4bfcc75c9c14
Public Version Date
June 10, 2022
Public Version Number
7
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 |