Duns Number:163610020
Device Description: UCP Home Drug Screening Test Cups 6 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY/A UCP Home Drug Screening Test Cups 6 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY/AMP
Catalog Number
U-CUP-664-RCN
Brand Name
UCP Home Drug Screening Test Cups
Version/Model Number
U-CUP-664-RCN
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"
Yes
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
K130463,K122419,K122419,K130463,K122419,K130463
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
10811885-dc6a-4ef4-a114-00d4414934f4
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
January 20, 2017
Package DI Number
20817038021617
Quantity per Package
8
Contains DI Package
10817038021610
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |