Duns Number:227530649
Device Description: The Methadone assay is an in vitro diagnostic test for the qualitative and semi-quantitati The Methadone assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of methadone in human urine.
Catalog Number
DA4016
Brand Name
MDONE
Version/Model Number
DA4016
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
K092272
Product Code
DJR
Product Code Name
Enzyme Immunoassay, Methadone
Public Device Record Key
b991991c-9d17-499e-be05-73bec05298fc
Public Version Date
December 21, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |