Other products from "NANOSPHERE, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00857573006164 20-006-024 The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult 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. OZE,OEM,OCC,OEP,OZZ,OOU Influenza A And Influenza B Multiplex Nucleic Acid Assay,Human Metapneumovirus ( Influenza A And Influenza B Multiplex Nucleic Acid Assay,Human Metapneumovirus (Hmpv) Rna Assay System,Respiratory Virus Panel Nucleic Acid Assay System,Influenza A Virus Subtype Differentiation Nucleic Acid Assay,Bordetella Pertussis Dna Assay System,Parainfluenza Multiplex Nucleic Acid Assay 2 Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
2 00857573006089 20-011-023 The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection. PCI,PCH Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastr Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System 2 Enteric Pathogens (EP) Amplification Tray
3 00857573006324 20-011-024 The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult 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. OZE,OEM,OCC,OEP,OZZ,OOU Influenza A And Influenza B Multiplex Nucleic Acid Assay,Human Metapneumovirus ( Influenza A And Influenza B Multiplex Nucleic Acid Assay,Human Metapneumovirus (Hmpv) Rna Assay System,Respiratory Virus Panel Nucleic Acid Assay System,Influenza A Virus Subtype Differentiation Nucleic Acid Assay,Bordetella Pertussis Dna Assay System,Parainfluenza Multiplex Nucleic Acid Assay 2 Respiratory Pathogens Flex (RP Flex) Amplification Tray
4 00857573006232 20-009-020 The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene 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. OCC Respiratory Virus Panel Nucleic Acid Assay System 2 Respiratory Virus Plus (RV+) Extraction Tray
5 00857573006010 10-0000-07 The Verigene® Processor SP is an instrument which integrates sample preparation, The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. OOI,NSU Real Time Nucleic Acid Amplification System,Instrumentation For Clinical Multipl Real Time Nucleic Acid Amplification System,Instrumentation For Clinical Multiplex Test Systems 2 Verigene® Processor SP
6 00857573006393 10-0000-02R The Verigene® Reader is the central control of the Verigene® System, a benchtop The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished) NSU,OOI Instrumentation For Clinical Multiplex Test Systems,Real Time Nucleic Acid Ampli Instrumentation For Clinical Multiplex Test Systems,Real Time Nucleic Acid Amplification System 2 Verigene® Reader (Refurbished)
7 00857573006362 30-002-022 The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative m The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). OZN C.Difficile Toxin Gene Amplification Assay 2 Clostridium difficile (CDF) Stool Sample Preparation Kit
8 00857573006249 20-009-021 The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. PEN Gram-Negative Bacteria And Associated Resistance Markers 2 Gram-Negative Blood Culture (BC-GN) Extraction Tray
9 00857573006287 20-011-018 The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed us The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). NQX,PAM System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen,Gram-Positive Bacteria And Their Resistance Markers 2 Gram-Positive Blood Culture (BC-GP) Utility Tray
10 00857573006133 20-006-020 The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene 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. OCC Respiratory Virus Panel Nucleic Acid Assay System 2 Respiratory Virus Plus (RV+) Nucleic Acid Test Cartridge
11 00857573006140 20-006-021 The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed us The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. PEN Gram-Negative Bacteria And Associated Resistance Markers 2 Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge
12 00857573006409 10-0000-07R The Verigene® Processor SP is an instrument which integrates sample preparation, The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished) NSU,OOI Instrumentation For Clinical Multiplex Test Systems,Real Time Nucleic Acid Ampli Instrumentation For Clinical Multiplex Test Systems,Real Time Nucleic Acid Amplification System 2 Verigene® Processor SP (Refurbished)
13 00857573006348 30-001-001 The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. NPQ,OMM,NPR Test, Factor V Leiden Mutations, Genomic Dna Pcr,Test 5, 10-Methylenetetrahydrof Test, Factor V Leiden Mutations, Genomic Dna Pcr,Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr,Test, Factor Ii G20210a Mutations, Genomic Dna Pcr 2 Hypercoagulation Panel (HC) Sample Buffer
14 00857573006317 20-011-022 The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative m The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). OZN C.Difficile Toxin Gene Amplification Assay 2 Clostridium difficile (CDF) Amplification Tray
15 00857573006058 20-009-023 The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection. PCI,PCH Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastr Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System 2 Enteric Pathogens (EP) Extraction Tray
16 00857573006300 20-011-021 The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed us The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. PEN Gram-Negative Bacteria And Associated Resistance Markers 2 Gram-Negative Blood Culture (BC-GN) Utility Tray
17 00857573006263 20-009-024 The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult 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. OZE,OEM,OCC,OEP,OZZ,OOU Influenza A And Influenza B Multiplex Nucleic Acid Assay,Human Metapneumovirus ( Influenza A And Influenza B Multiplex Nucleic Acid Assay,Human Metapneumovirus (Hmpv) Rna Assay System,Respiratory Virus Panel Nucleic Acid Assay System,Influenza A Virus Subtype Differentiation Nucleic Acid Assay,Bordetella Pertussis Dna Assay System,Parainfluenza Multiplex Nucleic Acid Assay 2 Respiratory Pathogens Flex (RP Flex) Extraction Tray
18 00857573006218 20-009-018 The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed us The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). NQX,PAM System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen,Gram-Positive Bacteria And Their Resistance Markers 2 Gram-Positive Blood Culture (BC-GP) Extraction Tray
19 00857573006027 20-006-001 The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. NPQ,OMM,NPR Test, Factor V Leiden Mutations, Genomic Dna Pcr,Test 5, 10-Methylenetetrahydrof Test, Factor V Leiden Mutations, Genomic Dna Pcr,Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr,Test, Factor Ii G20210a Mutations, Genomic Dna Pcr 2 Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge
20 00857573006003 10-0000-02 The Verigene® Reader is the central control of the Verigene® System, a benchtop The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. OOI,NSU Real Time Nucleic Acid Amplification System,Instrumentation For Clinical Multipl Real Time Nucleic Acid Amplification System,Instrumentation For Clinical Multiplex Test Systems 2 Verigene® Reader
21 00857573006386 10-0000-04 The Verigene® Processor is an instrument which internalizes all of the functions The Verigene® Processor is an instrument which internalizes all of the functions required to process a Test Cartridge as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. NSU Instrumentation For Clinical Multiplex Test Systems 2 Verigene® Processor
22 00857573006256 20-009-022 The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative m The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). OZN C.Difficile Toxin Gene Amplification Assay 2 Clostridium difficile (CDF) Extraction Tray
23 00857573006157 20-006-022 The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative mul The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). OZN C.Difficile Toxin Gene Amplification Assay 2 Clostridium difficile (CDF) Nucleic Acid Test Cartridge
24 00857573006119 20-006-018 The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). NQX,PAM System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococc System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen,Gram-Positive Bacteria And Their Resistance Markers 2 Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge
25 00857573006065 30-002-023 The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection. PCI,PCH Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastr Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System 2 Enteric Pathogens (EP) Stool Sample Preparation Kit
26 00857573006041 20-006-023 The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualita The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection. PCI,PCH Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastr Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System,Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System 2 Enteric Pathogens (EP) Nucleic Acid Test Cartridge
Other products with the same Product Code "OCC"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00840487101711 20-011-024 20-011-024 The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multip 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. Respiratory Pathogens Flex (RP Flex) Amplification Tray LUMINEX CORPORATION
2 00840487101667 20-009-024 20-009-024 The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multip 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. Respiratory Pathogens Flex (RP Flex) Extraction Tray LUMINEX CORPORATION
3 00840487101612 20-006-024 20-006-024 The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multip 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. Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge LUMINEX CORPORATION
4 00840487100486 I025C0197 I025C0197 The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected ofrespiratory tract infections xTAG® RVP FAST (Respiratory Viral Panel Fast) LUMINEX MOLECULAR DIAGNOSTICS, INC
5 00840487100462 I019C0111 I019C0111 The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections. xTAG® RVP (Respiratory Viral Panel) LUMINEX MOLECULAR DIAGNOSTICS, INC
6 00840487100417 I051C0447 I051C0447 The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. NxTAG® Respiratory Pathogen Panel LUMINEX MOLECULAR DIAGNOSTICS, INC
7 00840487100158 50-10020 The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualit The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swabs (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. ARIES® Flu A/B & RSV Assay LUMINEX CORPORATION
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13 B540FAB1100CWC0 FAB1100CW-C FAB1100CW-1 The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qua The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Accula™ Flu A / B Test. Accula Flu A / B Control Kit MESA BIOTECH, INC.
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15 B540D20010 D2001 D2001 The Programming Cassette is an accessory to the Accula Dock and facilitates repr 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 Accula Programming Cassette MESA BIOTECH, INC.
16 B540D20000 D2000 D2000 The Accula Dock is an electronic module which executes in vitro diagnostic tests 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. Accula Dock MESA BIOTECH, INC.
17 B54010400 1040 1040 The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro dia 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. Silaris RSV Supplemental Pack MESA BIOTECH, INC.
18 B54010350 1035 1035 The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in 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. Sialris Influenza A&B Supplemental Pack MESA BIOTECH, INC.
19 B54010290 1029 1029 The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality c The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test Silaris RSV Control Kit MESA BIOTECH, INC.
20 B54010280 1028 1028 The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) 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. SilarisTM Influenza A&B Starter Pack MESA BIOTECH, INC.
21 B54010270 1027 1027 The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in 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. Silaris Influenza A&B Test MESA BIOTECH, INC.
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