Duns Number:168560402
Device Description: 12 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI-OXY-TCA-THC-pH,SG,OX-CR,NI
Catalog Number
61211-5
Brand Name
DrugCheck
Version/Model Number
61211-5
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 26, 2019
Issuing Agency
In HIBCC
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
32fdc7fd-f729-4626-a790-c1967d83c4d3
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 12, 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. | 522 |
U | Unclassified | 2 |