Duns Number:790175165
Device Description: Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / OPI / OXY / MTD
Catalog Number
07RD7065-39
Brand Name
QuickProfile™ Drugs of Abuse Panel 6 Test
Version/Model Number
07RD7065-39
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
5f30d52f-20ca-4194-8ad0-beb744fa6ff1
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
November 15, 2017
Package DI Number
M90107RD7065391
Quantity per Package
25
Contains DI Package
M90107RD7065390
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK
| 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 |