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Respiratory Virus Panel Nucleic Acid Assay System

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Description
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Accula Flu A / B Control Kit
MESA BIOTECH, INC.
The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Accula™ Flu A / B Test.
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Accula Flu A / B Test
MESA BIOTECH, INC.
The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Accula Flu A / B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus.
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Accula Programming Cassette
MESA BIOTECH, INC.
The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware
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Accula Dock
MESA BIOTECH, INC.
The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of anelectro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary toorchestrate in-vitro diagnostic tests within the inserted Test Cassette.
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Silaris RSV Supplemental Pack
MESA BIOTECH, INC.
The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chainreaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA.The Silaris RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection.The Silaris RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinicaland epidemiological risk factors.
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Sialris Influenza A&B Supplemental Pack
MESA BIOTECH, INC.
The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus.
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Silaris RSV Control Kit
MESA BIOTECH, INC.
The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test
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SilarisTM Influenza A&B Starter Pack
MESA BIOTECH, INC.
The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location.
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Silaris Influenza A&B Test
MESA BIOTECH, INC.
The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus.
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Silaris Influenza A&B Control Kit
MESA BIOTECH, INC.
The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Silaris™ Influenza A&B Test.
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Solana
DIAGNOSTIC HYBRIDS, INC.
Solana RSV/hMPB Assay
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Solana
DIAGNOSTIC HYBRIDS, INC.
Solana Infulenza A+B Assay
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Lyra
QUIDEL CORPORATION
Lyra Adenovirus Assay
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Lyra
DIAGNOSTIC HYBRIDS, INC.
Lyra RSV+HMPV Assay
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Lyra
DIAGNOSTIC HYBRIDS, INC.
Lyra FLU A+B Assay
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Simplexa™ Flu A/B & RSV Positive Control Pack
DIASORIN MOLECULAR LLC
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Simplexa™ Flu A/B & RSV Direct
DIASORIN MOLECULAR LLC
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Simplexa™ Flu A/B & RSV
DIASORIN MOLECULAR LLC
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PANTHER FUSION
Hologic, Inc.
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PANTHER FUSION
Hologic, Inc.
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PANTHER FUSION
Hologic, Inc.
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PANTHER FUSION
Hologic, Inc.
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PANTHER FUSION
Hologic, Inc.
0
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PANTHER FUSION
Hologic, Inc.
0
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PANTHER FUSION
Hologic, Inc.
0
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PANTHER FUSION
Hologic, Inc.
0
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PANTHER FUSION
Hologic, Inc.
0
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PANTHER FUSION
Hologic, Inc.
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PRODESSE
Hologic, Inc.
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PRODESSE
Hologic, Inc.
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PRODESSE
Hologic, Inc.
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PRODESSE
Hologic, Inc.
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Idylla™ Respiratory (IFV-RSV) Panel
Biocartis NV
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cobas® Liat® Influenza A/B Script
Roche Molecular Systems, Inc.
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Xpert Xpress Flu
CEPHEID
Xpert Xpress Flu kit; 10 test kit
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Xpert Xpress Flu/RSV
CEPHEID
Xpert Xpress Flu/RSV kit; 10 test kit
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Xpert Flu+RSV Xpress
CEPHEID
Xpert Flu+RSV Xpress kit; 10 test kit
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Xpert Flu
CEPHEID
Xpert Flu kit; 10 test kit
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Xpert FLU/RSV XC
CEPHEID
Xpert FLU/RSV XC kit; 10 test kit
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QIAstat-Dx® Respiratory Panel
QIAGEN GmbH
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ARGENE® ADENOVIRUS R-gene KIT US
BIOMERIEUX SA
ADENOVIRUS R-gene® KIT US is a RT-PCR test is to aid in the diagnosis of respiratory Adenovirus infection in humans in conjunction with other clinical and laboratory findings.
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cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System
Roche Molecular Systems, Inc.
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cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System
Roche Molecular Systems, Inc.
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cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System
Roche Molecular Systems, Inc.
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cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System
Roche Molecular Systems, Inc.
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Respiratory Pathogens Flex (RP Flex) Amplification Tray
NANOSPHERE, INC.
The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.
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Respiratory Virus Plus (RV+) Amplification Tray
NANOSPHERE, INC.
The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
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Respiratory Pathogens Flex (RP Flex) Extraction Tray
NANOSPHERE, INC.
The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.
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Respiratory Virus Plus (RV+) Extraction Tray
NANOSPHERE, INC.
The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
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Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
NANOSPHERE, INC.
The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.
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