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 |
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. |
13 | 30014613336143 | M306 | M306 | Solana RSV/hMPB Assay | Solana | DIAGNOSTIC HYBRIDS, INC. |
14 | 30014613336068 | M300 | M300 | Solana Infulenza A+B Assay | Solana | DIAGNOSTIC HYBRIDS, INC. |
15 | 30014613312093 | Bordetella Assay | M209 | AmpliVue Bordetella Assay | AmpliVue | QUIDEL CORPORATION |
16 | 30014613311140 | Parainfluenza Virus Assay | M114 | Lyra Parainfluenza Assay | Lyra | QUIDEL CORPORATION |
17 | 30014613311133 | Adenovirus Assay | M113 | Lyra Adenovirus Assay | Lyra | QUIDEL CORPORATION |
18 | 30014613311034 | M103 | M103 | Lyra RSV+HMPV Assay | Lyra | DIAGNOSTIC HYBRIDS, INC. |
19 | 30014613311034 | M103 | M103 | Lyra RSV+HMPV Assay | Lyra | DIAGNOSTIC HYBRIDS, INC. |
20 | 30014613311003 | M100 | M100 | Lyra FLU A+B Assay | Lyra | DIAGNOSTIC HYBRIDS, INC. |
21 | 20816101025637 | MOL2760 | MOL2760 | Simplexa™ Bordetella Positive Control Pack | Simplexa™ Bordetella Positive Control Pack | DIASORIN MOLECULAR LLC |
22 | 20816101025620 | MOL2750 | MOL2750 | Simplexa™ Bordetella Direct | Simplexa™ Bordetella Direct | DIASORIN MOLECULAR LLC |
23 | 20816101025552 | MOL2660 | Simplexa™ Flu A/B & RSV Positive Control Pack | DIASORIN MOLECULAR LLC | ||
24 | 20816101025545 | MOL2650 | Simplexa™ Flu A/B & RSV Direct | DIASORIN MOLECULAR LLC | ||
25 | 20816101025538 | MOL2600 | Simplexa™ Flu A/B & RSV | DIASORIN MOLECULAR LLC | ||
26 | 15420045509337 | PARAFLU CTRLS KIT, PANTHER FUSION, IVD | PRD-04337 | PANTHER FUSION | HOLOGIC, INC. | |
27 | 15420045509320 | AMR CTRLS, PANTHER FUSION, IVD | PRD-04338 | PANTHER FUSION | HOLOGIC, INC. | |
28 | 15420045509313 | FLU A B RSV CTRLS, PANTHER FUSION, IVD | PRD-04336 | PANTHER FUSION | HOLOGIC, INC. | |
29 | 15420045509306 | PARAFLU KIT, PANTHER FUSION, 96T, IVD | PRD-04329 | PANTHER FUSION | HOLOGIC, INC. | |
30 | 15420045509290 | AMR KIT, PANTHER FUSION, 96T, IVD | PRD-04330 | PANTHER FUSION | HOLOGIC, INC. | |
31 | 15420045509283 | FLU A B RSV, PANTHER FUSION, 96T, IVD | PRD-04328 | PANTHER FUSION | HOLOGIC, INC. | |
32 | 15420045509276 | OIL KIT, PANTHER FUSION, 1920T, IVD | PRD-04335 | PANTHER FUSION | HOLOGIC, INC. | |
33 | 15420045509269 | ELUTION KIT, PANTHER FUSION, 2400T, IVD | PRD-04334 | PANTHER FUSION | HOLOGIC, INC. | |
34 | 15420045509252 | RECON-1 KIT, PANTHER FUSION, 1920T, IVD | PRD-04333 | PANTHER FUSION | HOLOGIC, INC. | |
35 | 15420045509238 | SPECIMEN LYSIS TUBES, IVD | PRD-04339 | PANTHER FUSION | HOLOGIC, INC. | |
36 | 15420045509221 | INTERNAL CONTROL-S, 960T, IVD | PRD-04332 | PANTHER FUSION | HOLOGIC, INC. | |
37 | 15420045509214 | EXTRACTION REAGENT-S, 960T, IVD | PRD-04331 | PANTHER FUSION | HOLOGIC, INC. | |
38 | 15420045506398 | PROPARAFLU+ KIT, 100 REACTIONS | 303677 | PRODESSE | HOLOGIC, INC. | |
39 | 15420045506381 | PROADENO+ KIT, 100 REACTIONS | 303675 | PRODESSE | HOLOGIC, INC. | |
40 | 15420045506367 | PRO HMPV+ KIT, 100 REACTIONS | 303671 | PRODESSE | HOLOGIC, INC. | |
41 | 15420045506343 | PROFLU+ ASSAY KIT, 1,500 REACTIONS | 303123 | PRODESSE | HOLOGIC, INC. | |
42 | 15420045506336 | PROFLU+ ASSAY KIT, 2,000 REACTIONS | 303121 | PRODESSE | HOLOGIC, INC. | |
43 | 15420045506329 | PRODESSE PROFLU+ ASSAY | 303111 | PRODESSE | HOLOGIC, INC. | |
44 | 15415219000635 | 1.0 | A1030/6 | Idylla™ Respiratory (IFV-RSV) Panel | BIOCARTIS NV | |
45 | 07613336129685 | 08085463001 | 08085463001 | cobas® Liat® Influenza A/B Script | ROCHE MOLECULAR SYSTEMS, INC. | |
46 | 07332940006044 | XPRSFLU-10 | XPRSFLU-10 | Xpert Xpress Flu kit; 10 test kit | Xpert Xpress Flu | CEPHEID |
47 | 07332940005696 | XPRSFLU/RSV-10 | XPRSFLU/RSV-10 | Xpert Xpress Flu/RSV kit; 10 test kit | Xpert Xpress Flu/RSV | CEPHEID |
48 | 07332940005177 | GXFLU+RSV-XP-10 | GXFLU+RSV-XP-10 | Xpert Flu+RSV Xpress kit; 10 test kit | Xpert Flu+RSV Xpress | CEPHEID |
49 | 07332940001070 | GXFLU-10A | GXFLU-10A | Xpert Flu kit; 10 test kit | Xpert Flu | CEPHEID |
50 | 07332940000783 | GXFLU/RSV-10 | GXFLU/RSV-10 | Xpert FLU/RSV XC kit; 10 test kit | Xpert FLU/RSV XC | CEPHEID |