Duns Number:174517060
Device Description: QuikSreen 11 Drug Cup Test: AMP1000, BAR300, BUP10, BZD300, COC300, MAD300, MDMA500, MET1 QuikSreen 11 Drug Cup Test: AMP1000, BAR300, BUP10, BZD300, COC300, MAD300, MDMA500, MET1000, OPI300, OXY100, THC50
Catalog Number
-
Brand Name
QuikSreen 11 Drug Cup Test
Version/Model Number
60B13
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
K122064,K071489,K122064,K130275,K071489,K122064,K130275,K071489,K130275
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
b53ed8a4-f36c-4588-b628-32d04d2088cc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 2016
Package DI Number
20748349000049
Quantity per Package
4
Contains DI Package
10748349000042
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 |