Other products from "BIOFIRE DIAGNOSTICS, LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00815381020161 RFIT-ASY-0130 RFIT-ASY-0130 IVD reagent kit containing 6 tests OZZ,OZY,OZX,OTG,OOU,OEP,OEM,OCC Bordetella Pertussis Dna Assay System,Chlamydophila Pneumoniae Dna Assay System, Bordetella Pertussis Dna Assay System,Chlamydophila Pneumoniae Dna Assay System,Mycoplasma Pneumoniae Dna Assay System,Non-Sars Coronavirus Multiplex Nucleic Acid Assay,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 FilmArray® Respiratory Panel 2 (RP2)
2 00815381020154 RFIT-ASY-0129 RFIT-ASY-0129 IVD reagent kit containing 30 tests OZZ,OZY,OZX,OTG,OOU,OEP,OEM,OCC Bordetella Pertussis Dna Assay System,Chlamydophila Pneumoniae Dna Assay System, Bordetella Pertussis Dna Assay System,Chlamydophila Pneumoniae Dna Assay System,Mycoplasma Pneumoniae Dna Assay System,Non-Sars Coronavirus Multiplex Nucleic Acid Assay,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 FilmArray® Respiratory Panel 2 (RP2)
3 00815381020147 RFIT-ASY-0120 RFIT-ASY-0120 IVD reagent kit containing 30 tests. OZX,OZY,OZZ,OOI,OQW,OTG,OEP,OOU,OEM,OCC Mycoplasma Pneumoniae Dna Assay System,Chlamydophila Pneumoniae Dna Assay System Mycoplasma Pneumoniae Dna Assay System,Chlamydophila Pneumoniae Dna Assay System,Bordetella Pertussis Dna Assay System,Real Time Nucleic Acid Amplification System,2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification,Non-Sars Coronavirus Multiplex Nucleic Acid Assay,Influenza A Virus Subtype Differentiation Nucleic Acid Assay,Parainfluenza Multiplex Nucleic Acid Assay,Human Metapneumovirus (Hmpv) Rna Assay System,Respiratory Virus Panel Nucleic Acid Assay System 2 FilmArray® Respiratory Panel (RP) EZ
4 00815381020116 RFIT-ASY-0104 RFIT-ASY-0104 IVD reagent kit containing 6 tests. PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System 2 FilmArray® Gastrointestinal (GI) Panel
5 00815381020109 RFIT-ASY-0116 RFIT-ASY-0116 IVD reagent kit containing 30 tests. PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System 2 FilmArray® Gastrointestinal (GI) Panel
6 00815381020239 423883 IVD reagent kit containing 30 tests. QJR Reagents, 2019-Novel Coronavirus Nucleic Acid BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests
7 00815381020482 423738 IVD reagent kit containing 30 tests. QJR Reagents, 2019-Novel Coronavirus Nucleic Acid BioFire® Respiratory Panel 2.1 EUA
8 00815381020185 RFIT-ASY-0145 IVD reagent kit containing 6 tests QBH Lower Respiratory Microbial Nucleic Acid Detection System 2 FilmArray® Pneumonia Panel (Pneumo)
9 00815381020178 RFIT-ASY-0144 IVD reagent kit containing 30 tests QBH Lower Respiratory Microbial Nucleic Acid Detection System 2 FilmArray® Pneumonia Panel (Pneumo)
10 00815381020307 RFIT-ASY-0137 RFIT-ASY-0137 IVD reagent kit containing 6 tests OOI,NSU,PZF Real Time Nucleic Acid Amplification System,Instrumentation For Clinical Multipl Real Time Nucleic Acid Amplification System,Instrumentation For Clinical Multiplex Test Systems,Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System 2 FilmArray® Respiratory Panel 2 plus (RP2plus)
11 00815381020291 RFIT-ASY-0136 RFIT-ASY-0136 IVD reagent kit containing 30 tests NSU,OOI,PZF Instrumentation For Clinical Multiplex Test Systems,Real Time Nucleic Acid Ampli Instrumentation For Clinical Multiplex Test Systems,Real Time Nucleic Acid Amplification System,Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System 2 FilmArray® Respiratory Panel 2 plus (RP2plus)
12 00815381029089 HTFA-ASY-0003-W Refurbished IVD Instrument (FilmArray® Torch Module) NSU Instrumentation For Clinical Multiplex Test Systems 2 FilmArray® Torch Module
13 00815381029072 HTFA-ASY-0001-W Refurbished IVD Instrument (FilmArray® Torch System Base) NSU Instrumentation For Clinical Multiplex Test Systems 2 FilmArray® Torch System Base
14 00815381020284 HTFA-SUB-0103 HTFA-SUB-0103R Refurbished IVD instrument (Torch Module) NSU Instrumentation For Clinical Multiplex Test Systems 2 FilmArray® Torch Module
15 00815381020277 HTFA-SUB-0103 HTFA-SUB-0103 IVD Instrument (FilmArray® Torch Module). NSU Instrumentation For Clinical Multiplex Test Systems 2 FilmArray® Torch Module
16 00815381020260 HTFA-ASY-0104 HTFA-ASY-0104R Refurbished IVD Instrument (FilmArray® Torch System Base). NSU Instrumentation For Clinical Multiplex Test Systems 2 FilmArray® Torch System Base
17 00815381020253 HTFA-ASY-0104 HTFA-ASY-0104 IVD Instrument (FilmArray® Torch System Base). NSU Instrumentation For Clinical Multiplex Test Systems 2 FilmArray® Torch System Base
18 00815381020192 RFIT-ASY-0138 IVD reagent kit containing 30 kits. QSN Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System 2 BioFire® Joint Infection (JI) Panel
19 00815381029058 FLM2-ASY-0001-W Refurbished IVD Instrument (FilmArray® 2.0 Instrument). NSU Instrumentation For Clinical Multiplex Test Systems 2 FilmArray® 2.0 Instrument
20 00815381020338 RFIT-ASY-0147 IVD reagent kit containing 30 tests. PAM,PEO Gram-Positive Bacteria And Their Resistance Markers,Fungal Organisms, Nucleic Ac Gram-Positive Bacteria And Their Resistance Markers,Fungal Organisms, Nucleic Acid-Based Assay 2 BioFire® Blood Culture Identification 2 (BCID2) Panel
21 00815381020048 FLM2-ASY-0001 FLM2-ASY-0001R Refurbished IVD Instrument (FilmArray® 2.0 Instrument). NSU Instrumentation For Clinical Multiplex Test Systems 2 FilmArray® 2.0 Instrument
22 00815381020031 FLM2-ASY-0001 FLM2-ASY-0001 IVD Instrument (FilmArray® 2.0 Instrument). NSU Instrumentation For Clinical Multiplex Test Systems 2 FilmArray® 2.0 Instrument
23 00815381020024 FLM1-ASY-0001 FLM1-ASY-0001R Refurbished IVD Instrument (FilmArray® Instrument). NSU Instrumentation For Clinical Multiplex Test Systems 2 FilmArray® Instrument
24 00815381020017 FLM1-ASY-0001 FLM1-ASY-0001 IVD Instrument (FilmArray® Instrument) NSU Instrumentation For Clinical Multiplex Test Systems 2 FilmArray® Instrument
25 00815381020321 RFIT-ASY-0142 IVD reagent kit containing 6 tests QDS Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Mul Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System 2 FilmArray® Pneumonia Panel plus (Pneumoplus)
26 00815381020314 RFIT-ASY-0143 IVD reagent kit containing 30 tests QDS Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Mul Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System 2 FilmArray® Pneumonia Panel plus (Pneumoplus)
27 00815381020093 RFIT-ASY-0127 RFIT-ASY-0127 IVD reagent kit containing 6 tests. OOI,PAM,PEN Real Time Nucleic Acid Amplification System,Gram-Positive Bacteria And Their Res Real Time Nucleic Acid Amplification System,Gram-Positive Bacteria And Their Resistance Markers,Gram-Negative Bacteria And Associated Resistance Markers 2 FilmArray® BCID Panel
28 00815381020086 RFIT-ASY-0126 RFIT-ASY-0126 IVD reagent kit containing 30 tests. OOI,PAM,PEN Real Time Nucleic Acid Amplification System,Gram-Positive Bacteria And Their Res Real Time Nucleic Acid Amplification System,Gram-Positive Bacteria And Their Resistance Markers,Gram-Negative Bacteria And Associated Resistance Markers 2 FilmArray® BCID Panel
29 00815381020079 RFIT-ASY-0125 RFIT-ASY-0125 IVD reagent kit containing 6 tests. OCC,OOU,OEP,OTG,OZZ,OZX,OEM Respiratory Virus Panel Nucleic Acid Assay System,Parainfluenza Multiplex Nuclei Respiratory Virus Panel Nucleic Acid Assay System,Parainfluenza Multiplex Nucleic Acid Assay,Influenza A Virus Subtype Differentiation Nucleic Acid Assay,Non-Sars Coronavirus Multiplex Nucleic Acid Assay,Bordetella Pertussis Dna Assay System,Mycoplasma Pneumoniae Dna Assay System,Human Metapneumovirus (Hmpv) Rna Assay System 2 FilmArray® Respiratory Panel (RP)
30 00815381020529 423742 IVD reagent kit containing 30 tests. QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Oth Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents 2 BioFire® Respiratory Panel 2.1
31 00815381020130 RFIT-ASY-0119 RFIT-ASY-0119 IVD reagent kit containing 6 tests. PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System 2 FilmArray® Meningitis/Encephalitis (ME) Panel
32 00815381020123 RFIT-ASY-0118 RFIT-ASY-0118 IVD reagent kit containing 30 tests. PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System 2 FilmArray® Meningitis/Encephalitis (ME) Panel
Other products with the same Product Codes "OEM, OZX, OZZ, OTG, OEP, OOU, OCC"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 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.
2 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.
3 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.
4 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.
5 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.
6 B54010350 1035 1035 The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus. Sialris Influenza A&B Supplemental Pack MESA BIOTECH, INC.
7 B54010290 1029 1029 The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality c The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test Silaris RSV Control Kit MESA BIOTECH, INC.
8 B54010280 1028 1028 The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location. SilarisTM Influenza A&B Starter Pack MESA BIOTECH, INC.
9 B54010270 1027 1027 The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus. Silaris Influenza A&B Test MESA BIOTECH, INC.
10 B54010240 1024 1024 The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use i The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Silaris™ Influenza A&B Test. Silaris Influenza A&B Control Kit MESA BIOTECH, INC.
11 B178GBBORD100 GBBORD-10 GBBORD-10 Bordetella Direct Test Cartridge Bordetella Direct Test GREAT BASIN SCIENTIFIC, INC.
12 30014613336167 M308 M308 Solana Bordetella Complete Solana DIAGNOSTIC HYBRIDS, INC.
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17 30014613311133 Adenovirus Assay M113 Lyra Adenovirus Assay Lyra QUIDEL CORPORATION
18 30014613311034 M103 M103 Lyra RSV+HMPV Assay Lyra DIAGNOSTIC HYBRIDS, INC.
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20 30014613311003 M100 M100 Lyra FLU A+B Assay Lyra DIAGNOSTIC HYBRIDS, INC.
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