A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere i RSV - 435-000
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 respiratory syncytial virus (RSV) in a clinical specimen, using a nucleic acid technique (NAT).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OCC
Device Name: Respiratory Virus Panel Nucleic Acid Assay System
Device Class: 2
Physical State: A qualitative in vitro diagnostic assay intended to simultaneously detect, identify, and/or differentiate multiple respiratory virus nucleic acid extracted from human respiratory specimens or viral cultures. Detection and differentiation of specific virus RNA or DNA aids in the diagnosis of respiratory infections in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of infection with these viruses.
Definition: A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: A qualitative in vitro diagnostic assay intended to simultaneously detect, identify, and/or differentiate multiple respiratory virus nucleic acid extracted from human respiratory specimens or viral cultures. Detection and differentiation of specific virus RNA or DNA aids in the diagnosis of respiratory infections in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of infection with these viruses.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: In vitro diagnostic device
Regulation Number: 866.3980
Third Party Flag: N
Medical Specialty: MI
Code: OEM
Device Name: Human Metapneumovirus (Hmpv) Rna Assay System
Device Class: 2
Physical State: Human metapneumovirus (hMPV) RNA detection assay systems are devices that consist of reagents and instruments for the detection of hMPV RNA extracted from human respiratory specimens or viral cultures.
Definition: A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections.
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hMPV) RNA extracted from human respiratory specimens or viral cultures.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: in vitro diagnostic assay
Regulation Number: 866.3980
Third Party Flag: N
Medical Specialty: MI
Code: OOI
Device Name: Real Time Nucleic Acid Amplification System
Device Class: 2
Physical State: Should not include microarray or electrophoresis detection methods or instruments.
Definition: The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.2570
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 10811877010118
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