Duns Number:174517060
Device Description: QuikStrip Multidrug 1 Screening Dip Card Test - MAD 300 ng/ml
Catalog Number
-
Brand Name
QuikStrip MultiDrug X Screening Dip Card
Version/Model Number
30121
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
Product Code
DJR
Product Code Name
Enzyme Immunoassay, Methadone
Public Device Record Key
90c59798-0fb0-4118-b6b5-2b24d163b9ea
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 04, 2016
Package DI Number
10748349000189
Quantity per Package
25
Contains DI Package
00748349000182
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 |