No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00857167005153 | eSensor® Cystic Fibrosis (CF) | MT002015 | eSensor® Cystic Fibrosis (CF) Genotyping Test (24) | eSensor® XT-8 | |||
2 | 00857167005238 | eSensor® Thrombophilia Risk Test Reagent Test (TRT) | MT004008 | eSensor® Thrombophilia Risk Test Reagent Test Pack (TRT) (48) | eSensor® XT-8 | |||
3 | 00857167005146 | eSensor® Cystic Fibrosis (CF) | KT020657 | eSensor® Cystic Fibrosis Genotyping Test Cartridge Pouch (CF) (8) | eSensor® XT-8 | |||
4 | 00857167005139 | eSensor® Respiratory Viral Panel (RVP) | MT005101 | eSensor® Respiratory Viral Panel Reagent (RVP) (48) | eSensor® XT-8 | |||
5 | 00857167005221 | eSensor® Thrombophilia Risk Test (TRT) | MT004008 | eSensor® Thrombophilia Risk Test Amplification Reagents (TRT) (48) | eSensor® XT-8 | |||
6 | 00857167005184 | eSensor® Cystic Fibrosis (CF) | MT002014 | eSensor® Cystic Fibrosis Genotyping Test Reagent Pack (CF) (24) | eSensor® XT-8 | |||
7 | 00857167005214 | eSensor® Thrombophilia Risk Test (TRT) | MT004008 | eSensor® Thrombophilia Risk Test Detection Reagents (TRT) (48) | eSensor® XT-8 | |||
8 | 00857167005276 | Warfarin Sensitivity Test (WST) | MT002001 | eSensor® Warfarin Sensitivity Test Reagent Pack (WST) (24) | eSensor® XT-8 | |||
9 | 00857167005207 | eSensor® Thrombophilia Risk Test (TRT) | MT004013 | eSensor® Thrombophilia Risk Test (TRT) (48) | eSensor® XT-8 | |||
10 | 00857167005177 | eSensor® Cystic Fibrosis (CF) | MT002014 | eSensor® Cystic Fibrosis Genotyping Test Detection Reagents (CF) (24) | eSensor® XT-8 | |||
11 | 00857167005160 | eSensor® Cystic Fibrosis (CF) | MT002014 | eSensor® Cystic Fibrosis Genotyping Test Amplification Reagents (CF) (24) | eSensor® XT-8 | |||
12 | 00857167005252 | Warfarin Sensitivity Test (WST) | MT002001 | eSensor® Warfarin Sensitivity Test Detection Reagents (WST) (24) | eSensor® XT-8 | |||
13 | 00857167005245 | Warfarin Sensitivity Test (WST) | MT002001 | eSensor® Warfarin Sensitivity Test Amplification Reagents (24) | eSensor® XT-8 | |||
14 | 00857167005191 | eSensor® Thrombophilia Risk Test (TRT) | KT021053 | eSensor® Thrombophilia Risk Test Cartridge Pouch (TRT) (8) | eSensor® XT-8 | |||
15 | 00857167005122 | eSensor® Respiratory Viral Panel (RVP) | MT005101 | eSensor® Respiratory Viral Panel Detection Reagents (RVP) (48) | eSensor® XT-8 | |||
16 | 00857167005115 | eSensor® Respiratory Viral Panel (RVP) | MT005101 | eSensor® Respiratory Viral Panel Amplification Reagents (48) | eSensor® XT-8 | |||
17 | 00857167005108 | eSensor® Respiratory Viral Panel (RVP) | MT005100 | eSensor® Respiratory Viral Panel Cartridges (RVP) (48) | eSensor® XT-8 | |||
18 | 00857167005092 | eSensor® Respiratory Viral Panel (RVP) | KT021620 | eSensor® Respiratory Viral Panel Cartridge Pouch (RVP) (8) | eSensor® XT-8 | |||
19 | 00857167005061 | Warfarin Sensitivity Test (WST) | MT002000 | eSensor® Warfarin Sensitivity Test Cartridges (WST) (24) | eSensor® XT-8 | |||
20 | 00857167005047 | Warfarin Sensitivity Test (WST) | KT020591 | eSensor® Warfarin Sensitivity Test Cartridge Pouch (WST) (8) | eSensor® XT-8 | |||
21 | 00857167005337 | BCID-GP Cartridge Pouch | KT021791 | ePlex Blood Culture Identification Gram Positive (GP) Panel Cartridge Pouch | PEO,PEN,PAM | Fungal Organisms, Nucleic Acid-Based Assay,Gram-Negative Bacteria And Associated Fungal Organisms, Nucleic Acid-Based Assay,Gram-Negative Bacteria And Associated Resistance Markers,Gram-Positive Bacteria And Their Resistance Markers | 2 | ePlex |
22 | 00857167005320 | BCID-GP 12 Kit Box | EA003012 | ePlex Blood Culture Identification Gram Positive (GP) Panel 12-Kit Box | PEO,PEN,PAM | Fungal Organisms, Nucleic Acid-Based Assay,Gram-Negative Bacteria And Associated Fungal Organisms, Nucleic Acid-Based Assay,Gram-Negative Bacteria And Associated Resistance Markers,Gram-Positive Bacteria And Their Resistance Markers | 2 | ePlex |
23 | 00857167005306 | BCID-GN Cartridge Pouch | KT021836 | ePlex Blood Culture Identification Gram Negative (GN) Cartridge Pouch | PEO,PEN,PAM | Fungal Organisms, Nucleic Acid-Based Assay,Gram-Negative Bacteria And Associated Fungal Organisms, Nucleic Acid-Based Assay,Gram-Negative Bacteria And Associated Resistance Markers,Gram-Positive Bacteria And Their Resistance Markers | 2 | ePlex |
24 | 00857167005290 | BCID-FP 12 Kit Box | EA005012 | ePlex Blood Culture Identification Fungal Pathogen (FP) 12-test kit box | PEO,PEN,PAM | Fungal Organisms, Nucleic Acid-Based Assay,Gram-Negative Bacteria And Associated Fungal Organisms, Nucleic Acid-Based Assay,Gram-Negative Bacteria And Associated Resistance Markers,Gram-Positive Bacteria And Their Resistance Markers | 2 | ePlex |
25 | 00857167005283 | BCID_FP Cartridge Pouch | KT022279 | ePlex Blood Culture Identification Fungal Pathogen (FP) Cartridge Pouch | PEO,PEN,PAM | Fungal Organisms, Nucleic Acid-Based Assay,Gram-Negative Bacteria And Associated Fungal Organisms, Nucleic Acid-Based Assay,Gram-Negative Bacteria And Associated Resistance Markers,Gram-Positive Bacteria And Their Resistance Markers | 2 | ePlex |
26 | 00857167005009 | ePlex System Base | NSU | Instrumentation For Clinical Multiplex Test Systems | 2 | ePlex | ||
27 | 00857167005030 | ePlex Respiratory Panel (RP) | EA001012 | ePlex Respiratory Panel Kit, 12 test, IVD | OZY,OZX,OZE,OTG,OQW,OOU,OEP,OEM,OCC | Chlamydophila Pneumoniae Dna Assay System,Mycoplasma Pneumoniae Dna Assay System Chlamydophila Pneumoniae Dna Assay System,Mycoplasma Pneumoniae Dna Assay System,Influenza A And Influenza B Multiplex Nucleic Acid Assay,Non-Sars Coronavirus Multiplex Nucleic Acid Assay,2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification,Parainfluenza Multiplex Nucleic Acid Assay,Influenza A Virus Subtype Differentiation Nucleic Acid Assay,Human Metapneumovirus (Hmpv) Rna Assay System,Respiratory Virus Panel Nucleic Acid Assay System | 2 | ePlex System |
28 | 00857167005023 | ePlex Respiratory Panel (RP) | KT022006 | ePlex Sample Delivery Device RP Panel | OZY,OZX,OZE,OTG,OQW,OOU,OEP,OEM,OCC | Chlamydophila Pneumoniae Dna Assay System,Mycoplasma Pneumoniae Dna Assay System Chlamydophila Pneumoniae Dna Assay System,Mycoplasma Pneumoniae Dna Assay System,Influenza A And Influenza B Multiplex Nucleic Acid Assay,Non-Sars Coronavirus Multiplex Nucleic Acid Assay,2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification,Parainfluenza Multiplex Nucleic Acid Assay,Influenza A Virus Subtype Differentiation Nucleic Acid Assay,Human Metapneumovirus (Hmpv) Rna Assay System,Respiratory Virus Panel Nucleic Acid Assay System | 2 | ePlex System |
29 | 00857167005016 | ePlex Respiratory Panel (RP) | KT022287 | Respiratory Panel Cartridge | OZY,OZX,OZE,OTG,OQW,OOU,OEP,OEM,OCC | Chlamydophila Pneumoniae Dna Assay System,Mycoplasma Pneumoniae Dna Assay System Chlamydophila Pneumoniae Dna Assay System,Mycoplasma Pneumoniae Dna Assay System,Influenza A And Influenza B Multiplex Nucleic Acid Assay,Non-Sars Coronavirus Multiplex Nucleic Acid Assay,2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification,Parainfluenza Multiplex Nucleic Acid Assay,Influenza A Virus Subtype Differentiation Nucleic Acid Assay,Human Metapneumovirus (Hmpv) Rna Assay System,Respiratory Virus Panel Nucleic Acid Assay System | 2 | ePlex System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00815381020338 | RFIT-ASY-0147 | IVD reagent kit containing 30 tests. | BioFire® Blood Culture Identification 2 (BCID2) Panel | BIOFIRE DIAGNOSTICS, LLC | |
2 | 00815381020338 | RFIT-ASY-0147 | IVD reagent kit containing 30 tests. | BioFire® Blood Culture Identification 2 (BCID2) Panel | BIOFIRE DIAGNOSTICS, LLC | |
3 | 00815381020093 | RFIT-ASY-0127 | RFIT-ASY-0127 | IVD reagent kit containing 6 tests. | FilmArray® BCID Panel | BIOFIRE DIAGNOSTICS, LLC |
4 | 00815381020093 | RFIT-ASY-0127 | RFIT-ASY-0127 | IVD reagent kit containing 6 tests. | FilmArray® BCID Panel | BIOFIRE DIAGNOSTICS, LLC |
5 | 00815381020086 | RFIT-ASY-0126 | RFIT-ASY-0126 | IVD reagent kit containing 30 tests. | FilmArray® BCID Panel | BIOFIRE DIAGNOSTICS, LLC |
6 | 00815381020086 | RFIT-ASY-0126 | RFIT-ASY-0126 | IVD reagent kit containing 30 tests. | FilmArray® BCID Panel | BIOFIRE DIAGNOSTICS, LLC |
7 | B769ICCAAQA00000 | iCC-AAQA00000 | The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multipl The iCubate, Inc. iC-GN Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram negative bacteria, which may cause bloodstream infection (BSI). The iC-GN Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram negative bacilli. | iC-GN Assay | ICUBATE, INC | |
8 | B769ICCAAJA00000 | iCC-AAJA00000 | The iCubate, Inc. iC-GPC Assay for use on the iC-System is a qualitative, multip The iCubate, Inc. iC-GPC Assay for use on the iC-System is a qualitative, multiplexed, in vitro diagnostic test for the detection and identification of potentially pathogenic gram positive bacteria, which may cause bloodstream infection (BSI). The iC-GPC Assay is performed directly on positive blood cultures, confirmed by Gram stain to contain gram positive cocci. | iC-GPC Assay | ICUBATE, INC | |
9 | B178GBSIDR100 | GBSIDR-10 | GBSIDR-10 | Staph ID/R Blood Culture Panel | GREAT BASIN SCIENTIFIC, INC. | |
10 | 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. | Gram-Negative Blood Culture (BC-GN) Utility Tray | NANOSPHERE, INC. | |
11 | 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). | Gram-Positive Blood Culture (BC-GP) Utility Tray | NANOSPHERE, INC. | |
12 | 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. | Gram-Negative Blood Culture (BC-GN) Extraction Tray | NANOSPHERE, INC. | |
13 | 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). | Gram-Positive Blood Culture (BC-GP) Extraction Tray | NANOSPHERE, INC. | |
14 | 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. | Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge | NANOSPHERE, INC. | |
15 | 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). | Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge | NANOSPHERE, INC. | |
16 | 00857167005337 | BCID-GP Cartridge Pouch | KT021791 | ePlex Blood Culture Identification Gram Positive (GP) Panel Cartridge Pouch | ePlex | GENMARK DIAGNOSTICS, INC. |
17 | 00857167005337 | BCID-GP Cartridge Pouch | KT021791 | ePlex Blood Culture Identification Gram Positive (GP) Panel Cartridge Pouch | ePlex | GENMARK DIAGNOSTICS, INC. |
18 | 00857167005337 | BCID-GP Cartridge Pouch | KT021791 | ePlex Blood Culture Identification Gram Positive (GP) Panel Cartridge Pouch | ePlex | GENMARK DIAGNOSTICS, INC. |
19 | 00857167005320 | BCID-GP 12 Kit Box | EA003012 | ePlex Blood Culture Identification Gram Positive (GP) Panel 12-Kit Box | ePlex | GENMARK DIAGNOSTICS, INC. |
20 | 00857167005320 | BCID-GP 12 Kit Box | EA003012 | ePlex Blood Culture Identification Gram Positive (GP) Panel 12-Kit Box | ePlex | GENMARK DIAGNOSTICS, INC. |
21 | 00857167005320 | BCID-GP 12 Kit Box | EA003012 | ePlex Blood Culture Identification Gram Positive (GP) Panel 12-Kit Box | ePlex | GENMARK DIAGNOSTICS, INC. |
22 | 00857167005313 | BCID-GN 12 Kit Box | EA002012 | ePlex Blood Culture Identification Gram Negative (GN) Panel 12-test kit box | ePlex | GENMARK DIAGNOSTICS, INC. |
23 | 00857167005313 | BCID-GN 12 Kit Box | EA002012 | ePlex Blood Culture Identification Gram Negative (GN) Panel 12-test kit box | ePlex | GENMARK DIAGNOSTICS, INC. |
24 | 00857167005313 | BCID-GN 12 Kit Box | EA002012 | ePlex Blood Culture Identification Gram Negative (GN) Panel 12-test kit box | ePlex | GENMARK DIAGNOSTICS, INC. |
25 | 00857167005306 | BCID-GN Cartridge Pouch | KT021836 | ePlex Blood Culture Identification Gram Negative (GN) Cartridge Pouch | ePlex | GENMARK DIAGNOSTICS, INC. |
26 | 00857167005306 | BCID-GN Cartridge Pouch | KT021836 | ePlex Blood Culture Identification Gram Negative (GN) Cartridge Pouch | ePlex | GENMARK DIAGNOSTICS, INC. |
27 | 00857167005306 | BCID-GN Cartridge Pouch | KT021836 | ePlex Blood Culture Identification Gram Negative (GN) Cartridge Pouch | ePlex | GENMARK DIAGNOSTICS, INC. |
28 | 00857167005290 | BCID-FP 12 Kit Box | EA005012 | ePlex Blood Culture Identification Fungal Pathogen (FP) 12-test kit box | ePlex | GENMARK DIAGNOSTICS, INC. |
29 | 00857167005290 | BCID-FP 12 Kit Box | EA005012 | ePlex Blood Culture Identification Fungal Pathogen (FP) 12-test kit box | ePlex | GENMARK DIAGNOSTICS, INC. |
30 | 00857167005290 | BCID-FP 12 Kit Box | EA005012 | ePlex Blood Culture Identification Fungal Pathogen (FP) 12-test kit box | ePlex | GENMARK DIAGNOSTICS, INC. |
31 | 00857167005283 | BCID_FP Cartridge Pouch | KT022279 | ePlex Blood Culture Identification Fungal Pathogen (FP) Cartridge Pouch | ePlex | GENMARK DIAGNOSTICS, INC. |
32 | 00857167005283 | BCID_FP Cartridge Pouch | KT022279 | ePlex Blood Culture Identification Fungal Pathogen (FP) Cartridge Pouch | ePlex | GENMARK DIAGNOSTICS, INC. |
33 | 00857167005283 | BCID_FP Cartridge Pouch | KT022279 | ePlex Blood Culture Identification Fungal Pathogen (FP) Cartridge Pouch | ePlex | GENMARK DIAGNOSTICS, INC. |
34 | 00840487101698 | 20-011-021 | 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. | Gram-Negative Blood Culture (BC-GN) Utility Tray | LUMINEX CORPORATION |
35 | 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). | Gram-Positive Blood Culture (BC-GP) Utility Tray | LUMINEX CORPORATION |
36 | 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. | Gram-Negative Blood Culture (BC-GN) Extraction Tray | LUMINEX CORPORATION |
37 | 00840487101629 | 20-009-018 | 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). | Gram-Positive Blood Culture (BC-GP) Extraction Tray | LUMINEX CORPORATION |
38 | 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. | Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge | LUMINEX CORPORATION |
39 | 00840487101575 | 20-006-018 | 20-006-018 | 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). | Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge | LUMINEX CORPORATION |