Alinity c Amphetamine/Methamphetamine Reagent Kit 400 Tests

Alinity c Amphetamine/Methamphetamine Reagent Kit 400 Tests
Alinity - 09P4520

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple drugs belonging to the amphetamine and/or methamphetamine group(s) 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: 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

Code: DKZ

Device Name: Enzyme Immunoassay, Amphetamine

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: 862.3100

Third Party Flag: Y

Medical Specialty: TX

Device Id: 00380740172329

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