Duns Number:065602744
Device Description: Four Drug PreScreen Plus (CLIA Waived) Dip Card Combo: COC MET THC OPI
Catalog Number
-
Brand Name
Four Panel PreScreen Plus Dip Card
Version/Model Number
PS-DOA-144
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
-
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
d30fdc0f-1f91-4747-9753-b1ee5c96a127
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 08, 2017
Package DI Number
10851000007295
Quantity per Package
20
Contains DI Package
00851000007298
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |