Duns Number:790175165
Device Description: Immunoassay for the detection of the following drug substance(s) in human urine: Selecti Immunoassay for the detection of the following drug substance(s) in human urine: Selection of panel numbers between 1 to 9 from AMP / BAR / BZD / COC / M-AMP / MTD / OPI / PCP / THC
Catalog Number
74046-II
Brand Name
QuickProfile™ Drugs of Abuse Test Cup
Version/Model Number
74046-II
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
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
577468e7-ec5c-43f7-b121-f4e90feff509
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
November 14, 2019
Package DI Number
M90174046II1
Quantity per Package
1
Contains DI Package
M90174046II0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
EA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 117 |
| U | Unclassified | 2 |