Duns Number:023904428
Device Description: Drugs of Abuse Dip Cards 10 DRUG PANEL WITH ADULTERANTS
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-DTDC10P
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)
-
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
9ab8eb65-7543-4dc2-9043-6bc57b7b4b3e
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
June 18, 2020
Package DI Number
20612479255306
Quantity per Package
25
Contains DI Package
10612479255293
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |