Duns Number:173064457
Device Description: 9 Panel Cup Drug Test, AMP-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
Catalog Number
60967-3-ZC
Brand Name
ZeroChaos
Version/Model Number
60967-3-ZC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 26, 2019
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
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
e63dfc1a-b09b-463e-a960-5b272dbef0b5
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
April 27, 2018
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. | 9 |