Duns Number:174517060
Device Description: QuikScreen 11+3: AMP 1000, BAR 300, BUP 10, BZD 300, MAD 300, MDMA 500, MET 1000, OPI 2000 QuikScreen 11+3: AMP 1000, BAR 300, BUP 10, BZD 300, MAD 300, MDMA 500, MET 1000, OPI 2000, OXY 100, PCP 25, THC 50 + adulterants (pH/CRE/SG)
Catalog Number
-
Brand Name
QuikScreen 11+3 Drug Cup Test
Version/Model Number
65B14-10
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
K071489,K130275,K122064,K071489,K122064,K130275,K071489,K130275,K122064
Product Code
DIS
Product Code Name
Enzyme Immunoassay, Barbiturate
Public Device Record Key
239fefe0-0bba-4aee-ae89-fee2f0a731e8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20748349000018
Quantity per Package
4
Contains DI Package
10748349000011
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 |