Duns Number:174517060
Device Description: QuikScreen Multi 11 Drug Cup Test - AMP 1000, BAR 300, BZD 300, COC 300, MAD 300, MDMA 500 QuikScreen Multi 11 Drug Cup Test - AMP 1000, BAR 300, BZD 300, COC 300, MAD 300, MDMA 500, MET 1000, OPI 300, OXY 100, TCA 1000, THC 50
Catalog Number
-
Brand Name
QuikScreen Multi 11 Drug Cup Test
Version/Model Number
60B00
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,K071489,K071489,K130275,K130275
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
05fe406c-f72e-4239-a2ad-d05b83bde984
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 04, 2016
Package DI Number
10748349000103
Quantity per Package
25
Contains DI Package
00748349000106
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 |