Duns Number:064177324
Device Description: Identify® Diagnostics Drug Test Cups12-Panel Drug Screening Test CupTHC/COC/MOP/AMP/MET/PC Identify® Diagnostics Drug Test Cups12-Panel Drug Screening Test CupTHC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
Catalog Number
ID-CP12-BUP-AZ10
Brand Name
Identify®Diagnostics Drug Test Cups
Version/Model Number
ID-CP12-BUP-AZ10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
September 06, 2030
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,K130463,K130463
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
9957b0cb-fce3-421c-85ce-a3d0369d0e3c
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 09, 2020
Package DI Number
20850013035087
Quantity per Package
20
Contains DI Package
10850013035080
Package Discontinue Date
September 06, 2030
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. | 8 |