Duns Number:174517060
Device Description: QuikScreen 7+4 AMP 500, COC 150, MDMA 500, MET 500, OPI 2000, OXY 100, THC50 + PH/CRE/SG/N QuikScreen 7+4 AMP 500, COC 150, MDMA 500, MET 500, OPI 2000, OXY 100, THC50 + PH/CRE/SG/NBP Cat. 65732-7
Catalog Number
-
Brand Name
QuikScreen 7+4
Version/Model Number
65732-7
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 28, 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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K071489,K130275,K071489,K130275
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
81625b7d-e3b5-4572-888a-dd1af3495a64
Public Version Date
October 06, 2020
Public Version Number
1
DI Record Publish Date
September 28, 2020
Package DI Number
10748349000721
Quantity per Package
25
Contains DI Package
00748349000724
Package Discontinue Date
September 28, 2020
Package Status
Not in Commercial Distribution
Package Type
Kit Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |