The Methamphetamine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of methamphetamine in human urine.

The Methamphetamine assay is an in vitro diagnostic test for the qualitative and semi
METHAMP - DA4007

Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple drugs belonging to the amphetamine and/or methamphetamine group(s) in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Reagent is stable on board analyser for 28 days at approx 10°c

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LAF

Device Name: Gas Chromatography, Methamphetamine

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: 862.3610

Third Party Flag: Y

Medical Specialty: TX

Device Identifiers

Device Id: 05055273208009

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