Duns Number:019410187
Device Description: U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Scre U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/BUP/MDMA/MTD/OXY)
Catalog Number
USSCUPA-10MOB-3
Brand Name
UScreen®
Version/Model Number
USSCupA-10MOB-300CLIA
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182701,K182701
Product Code
NFT
Product Code Name
Test, Amphetamine, Over The Counter
Public Device Record Key
8e5b696a-b364-4077-9e58-f7366554fc80
Public Version Date
October 31, 2022
Public Version Number
5
DI Record Publish Date
January 13, 2021
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 |