Duns Number:019410187
Device Description: Drugs of Abuse Test Card, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
Catalog Number
-
Brand Name
ProScreen
Version/Model Number
PSDA-5M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 30, 2020
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)
Yes
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
225421ac-54ca-4769-98f7-03d711afaf9d
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
October 14, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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. | 122 |
| U | Unclassified | 1 |