Lyra Parainfluenza Assay
Lyra - Parainfluenza Virus Assay
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple serogroups of Beta-haemolytic Streptococcus bacteria in a clinical specimen, using a nucleic acid technique (NAT).
Environmental Conditions
- 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: OOU
Device Name: Parainfluenza Multiplex Nucleic Acid Assay
Device Class: 2
Physical State: Nucleic Acid Based Assay
Definition: A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human parainfluenza nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings.
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Multiplex nucleic acid assay
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: IVD
Regulation Number: 866.3980
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 30014613311140
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