Duns Number:019410187
Device Description: UScreen Drug Test Cup, Employment And Insurance Testing, Exempt: AMP, MET, BAR, BZO, BUP, UScreen Drug Test Cup, Employment And Insurance Testing, Exempt: AMP, MET, BAR, BZO, BUP, COC, OPI, OXY, THC, MDMA, MTD, FTY, TRA (CR, pH, OX).
Catalog Number
USSCupA-13FEN
Brand Name
UScreen®
Version/Model Number
USSCupA-13FEN
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
PUX
Product Code Name
Test, Amphetamine, Employment And Insurance Testing, Exempt
Public Device Record Key
d693acda-67fe-4ab6-8d55-ad15655fce64
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
February 09, 2018
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 |