Duns Number:064177324
Device Description: Identify® Diagnostics-Home Drug Testing Device Test Cups 12-Panel Drug Screening Test Cup Identify® Diagnostics-Home Drug Testing Device Test Cups 12-Panel Drug Screening Test Cup AMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/MOP/OXY/PCP/THC with Adulteration strip (S.G./CRE/pH)
Catalog Number
ID-CP12-BUP-ADULT-AZ5
Brand Name
Identify® Diagnostics-Home Drug Testing Device Test Cups
Version/Model Number
ID-CP12-BUP-ADULT-AZ5
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
-
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
b89b4e6f-74cc-4013-942a-410982c4541b
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
April 06, 2017
Package DI Number
20850721007451
Quantity per Package
40
Contains DI Package
10850721007454
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. | 8 |