Duns Number:045623154
Device Description: Pointe Methadone Metabolite (EDDP) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Me Pointe Methadone Metabolite (EDDP) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Methadone Metabolite (EDDP) Reagent Set is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methadone metabolite in human urine. The cutoff for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL for methadone metabolite. The assay is designed for prescription use on automated clinical chemistry analyzers.
Catalog Number
60-MM0380-100
Brand Name
Pointe Methadone Metabolite (EDDP) Reagent Set
Version/Model Number
60-MM0380-100
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
-
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
K031797
Product Code
DJR
Product Code Name
Enzyme Immunoassay, Methadone
Public Device Record Key
40748fcf-e432-4d3a-a494-78ef4500c6ce
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 25, 2020
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |