IVD reagent kit containing 30 tests.

IVD reagent kit containing 30 tests.
BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini - 424537

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (bacteria, fungi and/or viruses) associated with respiratory disease in a clinical specimen, using a nucleic acid technique (NAT). Organisms detected may include (but are not limited to) Streptococcus pneumoniae, influenza A, respiratory syncytial viruses A and B, rhinovirus, Haemophilus influenzae, Mycoplasma pneumoniae, Staphylococcus aureus, and/or enterovirus.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NSU

Device Name: Instrumentation For Clinical Multiplex Test Systems

Device Class: 2

Physical State: N/A

Definition: Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de

Submission Type ID: 4

Review Panel: CH

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: 862.2570

Third Party Flag: N

Medical Specialty: CH

Code: QOF

Device Name: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Device Class: 2

Physical State: A closed system disposable pouch that contains all necessary reagents for sample preparation, reverse transcription, polymerase chain reaction (PCR), and detection from multiple respiratory pathogens from a single nasopharyngeal swab specimen. The reagent pouch is hydrated with sample buffer and specimen to activate and is placed into an automated instrument to perform the sample preparation, PCR reaction, and detection for result generation.

Definition: A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A nucleic acid amplification test (NAAT). PCR-based.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Nasopharyngeal (i.e., upper respiratory) swab specimen.

Regulation Number: 866.3981

Third Party Flag: N

Medical Specialty: MI

Code: PGX

Device Name: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Device Class: 2

Physical State: May include automated/manual isothermal nucleic acid amplification, polymerase chain reaction, ligase chain reaction, sequence-based amplification

Definition: An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses nucleic acid amplification technology to detect Groups A, C and G Sreptococci

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Throat swab specimen

Regulation Number: 866.2680

Third Party Flag: N

Medical Specialty: MI

Code: OZE

Device Name: Influenza A And Influenza B Multiplex Nucleic Acid Assay

Device Class: 2

Physical State: Nucleic acid based assay

Definition: An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B 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 influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral 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

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

Device Id: 00815381020727

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