IVD reagent kit containing 30 tests.

IVD reagent kit containing 30 tests.
BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel - 424461

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: 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: 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: 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

Code: OTG

Device Name: Non-Sars Coronavirus Multiplex Nucleic Acid Assay

Device Class: 2

Physical State: Nucleic Acid Based Assay

Definition: A non-SARS coronavirus multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of coronavirus 229E, coronavirus NL63, coronavirus HKU1 and Coronavirus OC43 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 non-SARS coronavirus nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract non-SARS coronavirus 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: 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: OZX

Device Name: Mycoplasma Pneumoniae Dna Assay System

Device Class: 2

Physical State: Mycoplasma pneumoniae DNA detection assay systems are devices that consist of reagents and instruments for the detection of Mycoplasma pneumoniae DNA extracted from human respiratory specimens.

Definition: A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens. Detection of Mycoplasma pneumoniae DNA aids in the diagnosis of Mycoplasma pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

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 Mycoplasma pneumoniae DNA extracted from human respiratory specimens.

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: OZY

Device Name: Chlamydophila Pneumoniae Dna Assay System

Device Class: 2

Physical State: Chlamydophila pneumoniae DNA detection assay systems are devices that consist of reagents and instruments for the detection of Chlamydophila pneumoniae DNA extracted from human respiratory specimens.

Definition: A qualitative in vitro diagnostic assay intended to detect Chlamydophila pneumoniae DNA extracted from human respiratory specimens. Detection of Chlamydophila pneumoniae DNA aids in the diagnosis of Chlamydophila pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

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 Chlamydophila pneumoniae DNA extracted from human respiratory specimens.

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: OZZ

Device Name: Bordetella Pertussis Dna Assay System

Device Class: 2

Physical State: Bordetella pertussis DNA detection assay systems are devices that consist of reagents and instruments for the detection of Bordetella pertussis DNA extracted from human respiratory specimens.

Definition: A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

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 Bordetella pertussis DNA extracted from human respiratory specimens.

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

Device Id: 00815381020659

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