Duns Number:066886996
Device Description: 12 Panel Rapid Multi-Drug Test Cup
Catalog Number
CDTC121
Brand Name
MAXCHECK
Version/Model Number
CDTC121
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 12, 2018
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)
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
bb67b1e0-bfe3-4e46-a0dc-c02478b56d60
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
December 19, 2017
Package DI Number
10852359007066
Quantity per Package
25
Contains DI Package
00852359007069
Package Discontinue Date
December 12, 2018
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |