Pointe Methadone Metabolite (EDDP) Reagent Set 1 x 1000 mL R1, 1 x 375 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.

Pointe Methadone Metabolite (EDDP) Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Methadone Metabolite (EDDP) Reagent Set is an in vitro diagnostic test intended for the qualitative and semi
Pointe Methadone Metabolite (EDDP) Reagent Set - 60-MM0380-1L

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the methadone metabolite 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) in a clinical specimen, using an enzyme immunoassay (EIA) method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DJR

Device Name: Enzyme Immunoassay, Methadone

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: TX

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.3620

Third Party Flag: Y

Medical Specialty: TX

Device Id: 00811727018083

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A