Duns Number:251005005
Device Description: One Step DOA Cup + Adulteration Test (5.30.1) COC(150) EDDP(100) MOP(100) OXY(100) BZO(300 One Step DOA Cup + Adulteration Test (5.30.1) COC(150) EDDP(100) MOP(100) OXY(100) BZO(300) + CR/SG/pH
Catalog Number
-
Brand Name
Rapid Response
Version/Model Number
D5.30.1-1VA
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182738
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
02d95be7-f70f-43ec-8369-d19382f3a2d5
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 16, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |