Pointe Carisporodol Metabolite (SOMA) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Carisoprodol Metabolite (SOMA) Reagent Set is intended for the qualitative and semi-quantitative determination of carisoprodol metabolite (meprobamate) in human urine at a cutoff value of 100 ng/mL when calibrated against meprobamate. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

Pointe Carisporodol Metabolite (SOMA) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Carisoprodol Metabolite (SOMA) Reagent Set is intended for the qualitative and semi
Pointe Carisporodol Metabolite (SOMA) Reagent Set - 60-CM0740-100

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of carisoprodol 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: QBK

Device Name: Meprobamate Test System

Device Class: 2

Physical State: Enzyme immunoassay reagent kit

Definition: A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs).

Submission Type ID: 1

Review Panel: TX

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Enzyme immunoassay

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human specimens, urine

Regulation Number: 862.3590

Third Party Flag: Y

Medical Specialty: TX

Device Id: 00811727018380

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