Other products from "LUMINEX CORPORATION"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00840487101803 40-50035 Sheath Fluid PLUS is the delivery medium of the sample to the optics component. NSU Instrumentation for clinical multiplex test systems 2 xMAP® Sheath Fluid PLUS
2 00840487101797 40-50020 The MAGPIX Drive Fluid PLUS serves as the delivery medium that carries the sampl The MAGPIX Drive Fluid PLUS serves as the delivery medium that carries the sample to the optics component of the MAGPIX instrument. NSU Instrumentation for clinical multiplex test systems 2 MAGPIX® Drive Fluid PLUS (4PK)
3 00840487101315 3909 3909 Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens MVU REAGENTS,SPECIFIC,ANALYTE 1 MultiCode® EBV Primers
4 00840487101742 3928 3928 Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens MVU REAGENTS,SPECIFIC,ANALYTE 1 Multicode® Mycoplasma genitalium Primers
5 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. OCC,OZE,OZZ,OEM,OOU,OEP Respiratory virus panel nucleic acid assay system,Influenza A and influenza B mu Respiratory virus panel nucleic acid assay system,Influenza A and influenza B multiplex nucleic acid assay,Bordetella pertussis dna assay system,Human metapneumovirus (hmpv) rna assay system,Parainfluenza multiplex nucleic acid assay,Influenza a virus subtype differentiation nucleic acid assay 2 Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge
6 00840487101544 20-011-023 20-011-023 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. PCH,PCI Gastrointestinal pathogen panel multiplex nucleic acid-based assay system,Gastro Gastrointestinal pathogen panel multiplex nucleic acid-based assay system,Gastrointestinal bacterial panel multiplex nucleic acid-based assay system 2 Enteric Pathogens (EP) Amplification Tray
7 00840487101506 10-0000-04 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
8 00840487101490 10-0000-07R 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)
9 00840487101322 3909-21 3909-21 Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens MVU REAGENTS,SPECIFIC,ANALYTE 1 MultiCode® EBV Primers
10 00840487101216 3804-22 3804-22 Internal control used in real-time polymerase chain reaction (pcr) assays to det Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. OLD Internal polymerase chain reaction control, not assay specific 1 MHV Control Primers 3
11 00840487101209 3804-21 3804-21 Internal control used in real-time polymerase chain reaction (pcr) assays to det Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. OLD Internal polymerase chain reaction control, not assay specific 1 MHV Control Primers 3
12 00840487101193 3804 3804 Internal control used in real-time polymerase chain reaction (pcr) assays to det Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. OLD Internal polymerase chain reaction control, not assay specific 1 MHV Control Primers 3
13 00840487101186 3803-21 3803-21 Internal control used in real-time polymerase chain reaction (pcr) assays to det Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. OLD Internal polymerase chain reaction control, not assay specific 1 MHV Control Primers 2
14 00840487101179 3803 3803 Internal control used in real-time polymerase chain reaction (pcr) assays to det Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. OLD Internal polymerase chain reaction control, not assay specific 1 MHV Control Primers 2
15 00840487100332 LX200-CON-K25 xMAP Control Microspheres, Classification (CON1) and Reporter (CON2), are polyst xMAP Control Microspheres, Classification (CON1) and Reporter (CON2), are polystyrene microspheres that are internally labeled with fluorescent dyes. The control microspheres are intended to verify the calibration and optical integrity for the Luminex 100/200 System. Classification Control Microspheres verify both classification channels and the doublet discriminator channel (DD). Reporter Control Microspheres verify the reporter channel. NSU Instrumentation for clinical multiplex test systems 2 Luminex® 100/200™ Performance Verification Kit
16 00840487100288 MPXIVD-PVER-K25 The Luminex MAGPIX Performance Verification Kit is intended to verify the optica The Luminex MAGPIX Performance Verification Kit is intended to verify the optical calibration of the MAGPIX instrument. NSU Instrumentation for clinical multiplex test systems 2 MAGPIX® Performance Verification Kit
17 00840487100271 MPXIVD-CAL-K25 The Luminex MAGPIX Calibration Kit is intended to calibrate the optics of the MA The Luminex MAGPIX Calibration Kit is intended to calibrate the optics of the MAGPIX instrument. During calibration, the system adjusts LED current and calibration factors for CL1, CL2, and RP1 until those values match the imported target values, thus calibrating the classification map. NSU Instrumentation for clinical multiplex test systems 2 MAGPIX® Calibration Kit
18 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. OZE,OCC Influenza A and influenza B multiplex nucleic acid assay,Respiratory virus panel Influenza A and influenza B multiplex nucleic acid assay,Respiratory virus panel nucleic acid assay system 2 ARIES® Flu A/B & RSV Assay
19 00840487100080 ARIES M6V1 The ARIES® M1 System is a clinical multiplex test system that automates and inte The ARIES® M1 System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay. OOI real time Nucleic acid amplification system 2 ARIES® M1 System
20 00840487101766 VERIGENE-II-6M-IVD The VERIGENE® II System is an in vitro diagnostic (IVD) platform that performs n The VERIGENE® II System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The VERIGENE II System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as automated amplification, array hybridization, and detection of target nucleic acid sequences. NSU Instrumentation for clinical multiplex test systems 2 VERIGENE® II System
21 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. OEP,OCC,OZZ,OZE,OEM,OOU Influenza a virus subtype differentiation nucleic acid assay,Respiratory virus p Influenza a virus subtype differentiation nucleic acid assay,Respiratory virus panel nucleic acid assay system,Bordetella pertussis dna assay system,Influenza A and influenza B multiplex nucleic acid assay,Human metapneumovirus (hmpv) rna assay system,Parainfluenza multiplex nucleic acid assay 2 Respiratory Pathogens Flex (RP Flex) Amplification Tray
22 00840487101377 3916 3916 Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens MVU REAGENTS,SPECIFIC,ANALYTE 1 MultiCode® VZV Primers
23 00840487101353 3914 3914 Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens MVU REAGENTS,SPECIFIC,ANALYTE 1 MultiCode® Adenovirus Primers
24 00840487101162 3802-21 3802-21 Internal control used in real-time polymerase chain reaction (pcr) assays to det Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. OLD Internal polymerase chain reaction control, not assay specific 1 MHV Control Primers 1
25 00840487101155 3802 3802 Internal control used in real-time polymerase chain reaction (pcr) assays to det Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. OLD Internal polymerase chain reaction control, not assay specific 1 MHV Control Primers 1
26 00840487101124 3694-22 3694-22 Internal control used in real-time polymerase chain reaction (pcr) assays to det Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. OLD Internal polymerase chain reaction control, not assay specific 1 MHV DNA Amplification Control
27 00840487101117 3694-21 3694-21 Internal control used in real-time polymerase chain reaction (pcr) assays to det Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. OLD Internal polymerase chain reaction control, not assay specific 1 MHV DNA Amplification Control
28 00840487101100 3694 3694 Internal control used in real-time polymerase chain reaction (pcr) assays to det Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes. OLD Internal polymerase chain reaction control, not assay specific 1 MHV DNA Amplification Control
29 00840487100257 3927 3927 Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens MVU REAGENTS,SPECIFIC,ANALYTE 1 MultiCode® Mycoplasma pneumoniae Primers
30 00840487100219 3923 3923 Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens MVU REAGENTS,SPECIFIC,ANALYTE 1 MultiCode® Group A Strep Primers
31 00840487100073 50-10026 The ARIES® Extraction Kit is intended to extract nucleic acid from human biologi The ARIES® Extraction Kit is intended to extract nucleic acid from human biological specimens and universal transport media (UTM). OOI real time Nucleic acid amplification system 2 ARIES® Extraction Kit
32 00840487101780 40-50036 A concentrated version of xMAP® Sheath Fluid PLUS, when diluted is is the delive A concentrated version of xMAP® Sheath Fluid PLUS, when diluted is is the delivery medium of the sample to the optics component. NSU Instrumentation for clinical multiplex test systems 2 xMAP® Sheath Concentrate PLUS
33 00840487101735 30-002-022 30-002-022 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) Stool Sample Preparation Kit
34 00840487101643 20-009-021 20-009-021 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) Extraction Tray
35 00840487101278 3906-21 3906-21 Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens MVU REAGENTS,SPECIFIC,ANALYTE 1 MultiCode® CMV Primers
36 00840487101261 3906 3906 Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens MVU REAGENTS,SPECIFIC,ANALYTE 1 MultiCode® CMV Primers
37 00840487101230 3901 3901 Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens MVU REAGENTS,SPECIFIC,ANALYTE 1 MultiCode® Bordetella pertussis Primers
38 00840487101223 3900 3900 Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens MVU REAGENTS,SPECIFIC,ANALYTE 1 MultiCode® HSV Primers
39 00840487100295 50-10017 The ARIES® HSV 1 & 2 Assay is a polymerase chain reaction (PCR)-based qualitativ The ARIES® HSV 1 & 2 Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus (HSV) DNA from cutaneous and mucocutaneous lesion swab specimens. PGI Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutane Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutaneous lesion samples 2 ARIES® HSV 1&2 Assay
40 00840487100097 40-50000 Sheath fluid is the delivery medium of the sample to the optics component. NSU Instrumentation for clinical multiplex test systems 2 xMAP® Sheath Fluid
41 00840487101674 20-011-018 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
42 00840487101599 20-006-021 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
43 00840487101469 50-10041 The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) ba The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis. PGX,OOI Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system,real time Nucleic acid amplification system 2 ARIES® Group A Strep Assay
44 00840487101421 MPXDF-4PK-1 The MAGPIX Drive Fluid serves as the delivery medium that carries the sample to The MAGPIX Drive Fluid serves as the delivery medium that carries the sample to the optics component of the MAGPIX instrument. NSU Instrumentation for clinical multiplex test systems 2 MAGPIX® Drive Fluid
45 00840487101032 3711 3711 The MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit is a polymerase chain reaction The MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV 1 & 2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection. OQO Herpes simplex virus nucleic acid amplification assay 2 Mutlicode®-RTx HSV 1&2 Kit
46 00840487100448 CN-SW47 The SYNCT Software is a desktop application that can be utilized by an end-user The SYNCT Software is a desktop application that can be utilized by an end-user on a standalone computer, providing users the ability to operate general functions such as Order Management, with or without a Laboratory Information System (LIS), viewing test results, reviewing and preparing test reports, performing software administrative functions, and providing security control for permitted functions. OOI real time Nucleic acid amplification system 2 SYNCT™ Software
47 00840487100325 10-0000-02 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
48 00840487100059 50-10018 The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) bas The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Clostridium difficile (C. difficile) nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile infection (CDI). OZN C.Difficile toxin gene amplification assay 2 ARIES® C. difficile Assay
49 00840487101728 30-001-001 30-001-001 The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F 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. OMM,NPQ,NPR Test 5, 10-methylenetetrahydrofolate reductase mutations, genomic dna pcr,TEST, Test 5, 10-methylenetetrahydrofolate reductase mutations, genomic dna pcr,TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR,TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR 2 Hypercoagulation Panel (HC) Sample Buffer
50 00840487101537 ARIES M12V1 The ARIES® System is a clinical multiplex test system that automates and integra The ARIES® System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay. OOI real time Nucleic acid amplification system 2 ARIES® System
Other products with the same Product Code "OZZ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 B178GBBORD100 GBBORD-10 GBBORD-10 Bordetella Direct Test Cartridge Bordetella Direct Test GREAT BASIN SCIENTIFIC, INC.
2 30014613336167 M308 M308 Solana Bordetella Complete Solana DIAGNOSTIC HYBRIDS, INC.
3 30014613312093 Bordetella Assay M209 AmpliVue Bordetella Assay AmpliVue QUIDEL CORPORATION
4 20816101025637 MOL2760 MOL2760 Simplexa™ Bordetella Positive Control Pack Simplexa™ Bordetella Positive Control Pack DIASORIN MOLECULAR LLC
5 20816101025620 MOL2750 MOL2750 Simplexa™ Bordetella Direct Simplexa™ Bordetella Direct DIASORIN MOLECULAR LLC
6 04053228033905 V1 691221 QIAstat-Dx® Respiratory Panel QIAGEN GMBH
7 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. Respiratory Pathogens Flex (RP Flex) Amplification Tray NANOSPHERE, INC.
8 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. Respiratory Pathogens Flex (RP Flex) Extraction Tray NANOSPHERE, INC.
9 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. Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge NANOSPHERE, INC.
10 00851034007073 01 63-R0001 In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of res In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens. BioCode Respiratory Pathogen Panel APPLIED BIOCODE, INC.
11 00840733102226 480750 480750 The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader, The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.The Alethia Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome. The IS481 insertional element can also be found in B. holmesii and some B. bronchiseptica strains. Respiratory infections with B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the Alethia Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Alethia Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.Alethia Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Alethia™ Pertussis MERIDIAN BIOSCIENCE, INC.
12 00840733102141 479930 479930 The Alethia Pertussis External Control Kit contains Positive Control Reagent for The Alethia Pertussis External Control Kit contains Positive Control Reagent for use with the Alethia Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors. Alethia™ Pertussis External Control Kit MERIDIAN BIOSCIENCE, INC.
13 00840733101199 280750 280750 The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome.Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis MERIDIAN BIOSCIENCE, INC.
14 00840733101137 279930 279930 The illumigene Pertussis External Control Kit contains Positive Control Reagent The illumigene Pertussis External Control Kit contains Positive Control Reagent for use with the illumigene Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the illumigene Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program. illumigene Pertussis External Control Kit MERIDIAN BIOSCIENCE, INC.
15 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
16 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
17 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
18 00840487101452 50-10037 The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. ARIES® Bordetella Assay LUMINEX CORPORATION
19 00815381020161 RFIT-ASY-0130 RFIT-ASY-0130 IVD reagent kit containing 6 tests FilmArray® Respiratory Panel 2 (RP2) BIOFIRE DIAGNOSTICS, LLC
20 00815381020154 RFIT-ASY-0129 RFIT-ASY-0129 IVD reagent kit containing 30 tests FilmArray® Respiratory Panel 2 (RP2) BIOFIRE DIAGNOSTICS, LLC
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