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 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
7 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
8 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
9 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
10 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
11 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)
12 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
13 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
14 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. OCC Respiratory Virus Panel Nucleic Acid Assay System 2 Respiratory Virus Plus (RV+) 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 Codes "NSU, OOI"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00628055420101 01004880-ABC (20) 01004880-ABC (20) A box of 20 SNP CYP2C19 External Control Kits. Spartan RX CYP2C19 System SPARTAN BIOSCIENCE INC
2 00628055420095 01004880-ABC (10) 01004880-ABC (10) A box of 10 CYP2C19 External Control Kits. Spartan RX CYP2C19 System SPARTAN BIOSCIENCE INC
3 00628055420088 01004872-ABC 01004872-ABC A box of 20 CYP2C19 Sample Collection Kits. Spartan RX CYP2C19 System SPARTAN BIOSCIENCE INC
4 00628055420071 01004985 01004985 This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan RX Netbook (01003214) and the Spartan RX Printer (01003438). Spartan RX CYP2C19 System SPARTAN BIOSCIENCE INC
5 00628055420064 01004985 01004985 This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan R This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (01004777) and the Spartan RX Barcode Scanner (01003359). Spartan RX CYP2C19 System SPARTAN BIOSCIENCE INC
6 00628055420057 01003374, 01003372, and 01003373 01003374, 01003372, and 01003373 The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 Syst The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes: Carrying bag (01003374), Cold block (01003372), and Insulated box (01003373). Spartan RX CYP2C19 System SPARTAN BIOSCIENCE INC
7 00628055420040 01003359 01003359 Barcode Scanner supplied with the Spartan RX CYP2C19 System. Spartan RX CYP2C19 System SPARTAN BIOSCIENCE INC
8 00628055420033 01003438 01003438 Printer supplied with the Spartan RX CYP2C19 System Spartan RX CYP2C19 System SPARTAN BIOSCIENCE INC
9 00628055420026 01003214 01003214 Netbook supplied with the Spartan RX CYP2C19 System. Spartan RX CYP2C19 System SPARTAN BIOSCIENCE INC
10 00628055420019 01004777 01004777 Spartan RX Analyzer Spartan RX CYP2C19 System SPARTAN BIOSCIENCE INC
11 00628055344179 410400 410400 The Revogene® Strep A assay, performed on the Revogene® instrument, is an automa The Revogene® Strep A assay, performed on the Revogene® instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The Revogene Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection. Revogene® Strep A MERIDIAN BIOSCIENCE CANADA INC
12 00628055344162 410500 410500 The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualita The Revogene® Carba C assay, performed on the Revogene® instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The Revogene Carba C assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative Revogene Carba C assay result does not preclude the presence of other resistance mechanisms.The Revogene Carba C assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections. Revogene® Carba C MERIDIAN BIOSCIENCE CANADA INC
13 00628055344131 610208 610208 The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogen The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene® instrument and Revogene® assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run. MOCK PIE MERIDIAN BIOSCIENCE CANADA INC
14 00628055344117 410200 410200 The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome.The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Revogene® GBS LB MERIDIAN BIOSCIENCE CANADA INC
15 00628055344100 610210 610210 The Revogene® instrument is intended for in vitro diagnostic (IVD) use in perfor The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. The Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real time PCR. Revogene® MERIDIAN BIOSCIENCE CANADA INC
16 00628055344087 133674 133674 The GenePOC Strep A assay, performed on the revogene instrument, is an automated The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection. GenePOC™ Strep A GENEPOC INC
17 00628055344070 133499 133499 The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitativ The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The GenePOC Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC Carba assay result does not preclude the presence of other resistance mechanisms.The GenePOC Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections. GenePOC™ Carba GENEPOC INC
18 00628055344032 132331 132331 The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogen The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower then eight in a run. MOCK PIE GENEPOC INC
19 00628055344001 130840 130840 The revogene™ instrument is intended for in vitro diagnostic (IVD) use in perfor The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR. revogene™ GENEPOC INC
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35 B769ICRADAA00000 iCR-ADAA00000 The iC-System is an in vitro diagnostic device designed to perform multiplex amp The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets. iC-Reader ICUBATE, INC
36 B769ICPADAAA0000 iCP-ADAAA0000 The iC-System is an in vitro diagnostic device designed to perform multiplex amp The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets. iC-Processor ICUBATE, INC
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38 B550ENT0070 Testing Tray ENT007 Metal tray used to heat OpsisDx NuTec Slides OpsisDx ENTOPSIS, LLC
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44 B3959910030 9910030 9910030 WASH Solution used for the Vantera Clinical Analyzer NMR WASH Solution LABCORP OF AMERICA
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46 B178PA5000 PA500 PA500 PA500 Portrait Analyzer GREAT BASIN SCIENTIFIC, INC.
47 B178GBSTEC100 GBSTEC-10 GBSTEC-10 Shiga Toxin Direct Test Cartridge with sample prep device. Shiga Toxin Direct Test GREAT BASIN SCIENTIFIC, INC.
48 B178GBSIDR100 GBSIDR-10 GBSIDR-10 Staph ID/R Blood Culture Panel GREAT BASIN SCIENTIFIC, INC.
49 B178GBSBPP100 GBSBPP-10 GBSBPP-10 Stool Bacterial Pathogens Panel Cartridge with sample prep device. Stool Bacterial Pathogens Panel GREAT BASIN SCIENTIFIC, INC.
50 B178GBGBS100 GBGBS-10 GBGBS-10 Group B Strep Assay GREAT BASIN SCIENTIFIC, INC.