Simplexa™ Influenza A H1N1 (2009)

Simplexa™ Influenza A H1N1 (2009) - MOL2500

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from influenza A virus H1N1 subtype (swine influenza) in a clinical specimen, using a nucleic acid technique (NAT).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OQW

Device Name: 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

Device Class: 2

Physical State: Reagent Kit

Definition: 2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Nucleic acid amplification or antigen detection assays

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device

Regulation Number: 866.3332

Third Party Flag: N

Medical Specialty: MI

Device Id: 20816101025521

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