Duns Number:022637761
Device Description: CSI Cup - CLIA Screen In-Vitro 14 Panel Drug Test, Click Seal Cap, AMP500, BAR, BUP, BZO, CSI Cup - CLIA Screen In-Vitro 14 Panel Drug Test, Click Seal Cap, AMP500, BAR, BUP, BZO, COC150, mAMP500, MDMA, MOP300, MTD, OXY, PCP, PPX, TCA, THC, 25/BX
Catalog Number
-
Brand Name
CSI
Version/Model Number
CSI-CUP-1145S
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)
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
312f45ec-2f61-4333-be5f-d7dae9504b26
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 01, 2019
Package DI Number
00850798007794
Quantity per Package
25
Contains DI Package
00850798007787
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |