Duns Number:035967806
Device Description: Drugs of Abuse Test Cup for (COC/THC)+(PCP/AMP)+BZO+OPI+OXY with Cr, Ni, pH, Bl, S.G. (CLI Drugs of Abuse Test Cup for (COC/THC)+(PCP/AMP)+BZO+OPI+OXY with Cr, Ni, pH, Bl, S.G. (CLIA Waived)
Catalog Number
NBCA-7C-W
Brand Name
Noble 1 Step Cup
Version/Model Number
NBCA-7C-W
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K052115
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
45e25e46-0799-4ff4-97d8-1446b320e423
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 01, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 37 |