Duns Number:174517060
Device Description: DDS 5 Test COC 300, MET 1000, OPI 300, TCA 1000, THC 50
Catalog Number
-
Brand Name
QuikStrip
Version/Model Number
30539
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
K061617,K061617,K061617
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
6bb77d83-7522-4a2c-a55f-9ab08dc360f3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 16, 2017
Package DI Number
20748349000360
Quantity per Package
4
Contains DI Package
10748349000363
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |