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 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
19 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
20 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
21 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
22 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
23 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
24 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
25 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
26 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
27 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
28 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
29 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
30 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
31 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
32 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
33 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
34 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
35 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
36 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
37 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
38 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
39 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
40 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
41 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
42 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
43 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
44 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
45 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
46 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
47 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
48 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
49 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
50 00840487101476 10-0000-02R 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) 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 (Refurbished)
Other products with the same Product Codes "OZE, OCC"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 04053228033905 V1 691221 QIAstat-Dx® Respiratory Panel QIAGEN GMBH
2 03573026403997 69-010B-US ADENOVIRUS R-gene® KIT US is a RT-PCR test is to aid in the diagnosis of respira 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. ARGENE® ADENOVIRUS R-gene KIT US BIOMERIEUX SA
3 00875197005950 08160104190 08160104190 cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System ROCHE MOLECULAR SYSTEMS, INC.
4 00875197005950 08160104190 08160104190 cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System ROCHE MOLECULAR SYSTEMS, INC.
5 00875197005653 07402686190 07402686190 cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System ROCHE MOLECULAR SYSTEMS, INC.
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9 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.
10 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.
11 00857573006294 20-011-020 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. Respiratory Virus Plus (RV+) Amplification Tray NANOSPHERE, INC.
12 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.
13 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.
14 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. Respiratory Virus Plus (RV+) Extraction Tray NANOSPHERE, INC.
15 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.
16 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.
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24 00851458005112 1.5 FLM1-ASY-0121 NGDS FilmArray Instrument FILMARRAY BIOFIRE DEFENSE, LLC
25 00851458005068 JRPD-ASY-0137 JRPD-ASY-0137 JBAIDS IVD Influenza A & B Detection Kit JBAIDS BIOFIRE DEFENSE, LLC
26 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.
27 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.
28 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
29 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
30 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
31 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
32 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
33 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
34 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
35 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
36 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
37 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
38 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
39 00815381020161 RFIT-ASY-0130 RFIT-ASY-0130 IVD reagent kit containing 6 tests FilmArray® Respiratory Panel 2 (RP2) BIOFIRE DIAGNOSTICS, LLC
40 00815381020154 RFIT-ASY-0129 RFIT-ASY-0129 IVD reagent kit containing 30 tests FilmArray® Respiratory Panel 2 (RP2) BIOFIRE DIAGNOSTICS, LLC
41 00815381020147 RFIT-ASY-0120 RFIT-ASY-0120 IVD reagent kit containing 30 tests. FilmArray® Respiratory Panel (RP) EZ BIOFIRE DIAGNOSTICS, LLC
42 00815381020079 RFIT-ASY-0125 RFIT-ASY-0125 IVD reagent kit containing 6 tests. FilmArray® Respiratory Panel (RP) BIOFIRE DIAGNOSTICS, LLC
43 00815381020062 RFIT-ASY-0124 RFIT-ASY-0124 IVD reagent kit containing 30 tests. FilmArray® Respiratory Panel (RP) BIOFIRE DIAGNOSTICS, LLC
44 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.
45 B540FAB1100CW0 FAB1100CW FAB1100CW The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro 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. Accula Flu A / B Test MESA BIOTECH, INC.
46 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.
47 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.
48 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.
49 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.
50 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.