Duns Number:045623154
Device Description: Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate 1 x 5 mL The Pointe Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate 1 x 5 mL The Pointe Methadone Metabolite (EDDP) 100 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Methadone Metabolite (EDDP) Reagent Set (Ref# 60-MM0380-100/60-MM0380-1L) at the cutoff value of 100 ng/mL on automated clinical chemistry analyzers.
Catalog Number
60-MM0408-5
Brand Name
Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate
Version/Model Number
60-MM0408-5
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
DLJ
Product Code Name
Calibrators, Drug Specific
Public Device Record Key
ef1b780b-e63f-48bf-98c6-5d579789f90c
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 |