Duns Number:174517060
Device Description: QuikScreen Multi 8+5 Drug Cup Test - AMP 500, BUP 10, COC 300, MAD 300, MDMA 500, MET 500 QuikScreen Multi 8+5 Drug Cup Test - AMP 500, BUP 10, COC 300, MAD 300, MDMA 500, MET 500, OPI 300, THC 50, + pH/SG/NBP/GTA/CRE
Catalog Number
-
Brand Name
QuikScreen
Version/Model Number
65810-11
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K130275,K122064,K071489,K071489,K122064,K130275,K130275,K122064,K071489
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
b49c4fde-7d87-4725-9af1-637421bb6cce
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 19, 2016
Package DI Number
10748349000141
Quantity per Package
25
Contains DI Package
00748349000144
Package Discontinue Date
-
Package Status
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 |