Duns Number:075150847
Device Description: The Drugs of Abuse (DOA-5) Panel Test is set up as a one step in-vitro test based on immun The Drugs of Abuse (DOA-5) Panel Test is set up as a one step in-vitro test based on immunochromatography. It isdesigned for the qualitative determination of 5 drug substances, specifically Amphetamine, Benzodiazepine, Cocaine,Opiate, and Cannabinoid in human urine specimens.
Catalog Number
RAP-3773
Brand Name
Drugs of Abuse Five (5) Panel Test
Version/Model Number
RAP-3773
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K003809
Product Code
DKZ
Product Code Name
Enzyme immunoassay, amphetamine
Public Device Record Key
0984b4be-6be6-40d1-9e1a-d09e396afc38
Public Version Date
March 30, 2020
Public Version Number
2
DI Record Publish Date
June 10, 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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |