Duns Number:174517060
Device Description: QUIKSCREEN Multi 12 Drug Cup Test:AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, OPI 2000, M QUIKSCREEN Multi 12 Drug Cup Test:AMP 1000, BAR 300, BUP 10, BZD 300, COC 300, OPI 2000, MAD 300, MET 1000, PCP 25, OXY 100, TCA 1000, THC 50
Catalog Number
-
Brand Name
QuikScreen Multi 12 Drug Cup Test
Version/Model Number
60C09
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"
Yes
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
K122064,K130275,K130275,K122064,K071489,K071489,K122064,K130275,K071489
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
7dcc454d-7632-4530-8b0a-1a59dbae07bc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 21, 2016
Package DI Number
20748349000179
Quantity per Package
4
Contains DI Package
10748349000172
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper 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 |