Other products from "DIAGNOSTIC HYBRIDS, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 30014613339144 Coronavirus M124 SARS-CoV-2 Direct Assay QJR Reagents, 2019-novel coronavirus nucleic acid Lyra
2 30014613339090 Coronavirus M120 Lyra SARS-CoV-2 Assay QJR Reagents, 2019-novel coronavirus nucleic acid Lyra
3 30014613338727 01-124210 01-124210 L-DFA RSV/MPV Antigen Control Slides LJG QUALITY CONTROL SLIDES 1 D3 Fastpoint
4 30014613338710 01-124110 01-124110 L-DFA Influenza A/Influenza B Antigen Control Slides LJG QUALITY CONTROL SLIDES 1 D3 Fastpoint
5 30014613336440 M311 M311 Solana GBS Assay NJR Nucleic acid amplification assay system, group b streptococcus, direct specimen test 1 Solana
6 30014613337003 M123 M123 Solana RSV+hMPV Control Set OHQ Multi-analyte controls unassayed 1 Solana
7 30014613336990 M122 M122 Solana Flu A+B Control Set OHQ Multi-analyte controls unassayed 1 Solana
8 30014613336983 M118 M118 Solana HSV 1+2/ VZV Control set OHQ Multi-analyte controls unassayed 1 Solana
9 30014613336150 M307 M307 Solana C. difficile Assay OZN C. Difficile Toxin Gene Amplification Assay 2 Solana
10 30014613336143 M306 M306 Solana RSV/hMPB Assay OCC Respiratory virus panel nucleic acid assay system 2 Solana
11 30014613336136 M305 M305 Solana Strep A/C & G Assay PGX Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system 2 Solana
12 30014613336105 M302 M302 Solana HSV 1+2/ VZV Assay 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 Solana
13 30014613336068 M300 M300 Solana Infulenza A+B Assay OCC Respiratory virus panel nucleic acid assay system 2 Solana
14 30014613330929 01-215010 01-215010 D3 Duet DFA RSV Screening Reagent LKT RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA 1 D3 Duet
15 30014613330912 01-215002 01-215002 D3 Duet DFA RSV Screening Reagent 2ML LKT RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA 1 D3 Duet
16 30014613330905 01-210000 01-210000 D3 Duet DFA RSV/Respiratory Virus Screening Kit LKT RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA 1 D3 Duet
17 30014613330899 01-205010 01-205010 D3 Duet DFA Influenza A Screening reagent LKT RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA 1 D3 Duet
18 30014613330882 01-200000 01-200000 D3 Duet DFA Influenza A/Respiratory Virus Screening kit GNW ANTISERA, CF, INFLUENZA VIRUS A, B, C 1 D3 Duet
19 30014613330875 01-123504 01-123504 L-DFA Parainfluenza Virus/Adenovirus Reagent GNY,OMG,GQS,LKT,GNS ANTISERA, FLUORESCENT, ADENOVIRUS 1-33,Antisera, fluorescent, human metapneumovi ANTISERA, FLUORESCENT, ADENOVIRUS 1-33,Antisera, fluorescent, human metapneumovirus,ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4,RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,ANTISERA, HAI, INFLUENZA VIRUS A, B, C 1 D3 Fastpoint
20 30014613330868 01-123304 01-123304 L-DFA RSV/MPV Reagent LKT,OMG,GQS,GNS,GNY RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,Antisera, fluorescent, human RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,Antisera, fluorescent, human metapneumovirus,ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4,ANTISERA, HAI, INFLUENZA VIRUS A, B, C,ANTISERA, FLUORESCENT, ADENOVIRUS 1-33 1 D3 Fastpoint
21 30014613330851 01-123104 01-123104 L-DFA Influenza A/Influenza B Reagent LKT,GNY,GQS,GNS,OMG RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,ANTISERA, FLUORESCENT, ADENO RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,ANTISERA, FLUORESCENT, ADENOVIRUS 1-33,ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4,ANTISERA, HAI, INFLUENZA VIRUS A, B, C,Antisera, fluorescent, human metapneumovirus 1 D3 Fastpoint
22 30014613330844 01-122006 01-122006 Re-Suspension Buffer LKT,GNY,OMG,GNS,GQS RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,ANTISERA, FLUORESCENT, ADENO RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,ANTISERA, FLUORESCENT, ADENOVIRUS 1-33,Antisera, fluorescent, human metapneumovirus,ANTISERA, HAI, INFLUENZA VIRUS A, B, C,ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4 1 D3 Fastpoint
23 30014613330837 01-120002.B2 01-120002.B2 FASTPOINT RSV/MPV KIT BX 2 LKT,OMG RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,Antisera, fluorescent, human RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,Antisera, fluorescent, human metapneumovirus 1 D3 Fastpoint
24 30014613330820 01-120002.B1 01-120002.B1 FASTPOINT RSV/MPV KIT BX 1 LKT,OMG RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,Antisera, fluorescent, human RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,Antisera, fluorescent, human metapneumovirus 1 D3 Fastpoint
25 30014613330813 RSV/MPV ID Kit 01-120002 D3 FASTPOINT RSV/MPV KIT OMG,LKT Antisera, fluorescent, human metapneumovirus,RESPIRATORY SYNCYTIAL VIRUS, ANTIGE Antisera, fluorescent, human metapneumovirus,RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA 1 D3 Fastpoint
26 30014613330806 01-120001.B2 01-120001.B2 FASTPOINT FLUA/B KIT BX 2 GNW ANTISERA, CF, INFLUENZA VIRUS A, B, C 1 D3 Fastpoint
27 30014613330790 01-120001.B1 01-120001.B1 FASTPOINT FLUA/B KIT BX 1 GNW ANTISERA, CF, INFLUENZA VIRUS A, B, C 1 D3 Fastpoint
28 30014613330783 01-120001 01-120001 FASTPOINT FLUA/B KIT GNW ANTISERA, CF, INFLUENZA VIRUS A, B, C 1 D3 Fastpoint
29 30014613330776 01-120000.B2 01-120000.B2 D3 FASTPOINT LDFA VIR IDKIT BX LKT,GNS,GNY,GQS,OMG RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,ANTISERA, HAI, INFLUENZA VIR RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,ANTISERA, HAI, INFLUENZA VIRUS A, B, C,ANTISERA, FLUORESCENT, ADENOVIRUS 1-33,ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4,Antisera, fluorescent, human metapneumovirus 1 D3 Fastpoint
30 30014613330769 01-120000.B1 01-120000.B1 D3 FASTPOINT LDFA VIR IDKIT BX GQS,OMG,GNS,LKT,GNY ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4,Antisera, fluoresce ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4,Antisera, fluorescent, human metapneumovirus,ANTISERA, HAI, INFLUENZA VIRUS A, B, C,RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,ANTISERA, FLUORESCENT, ADENOVIRUS 1-33 1 D3 Fastpoint
31 30014613330752 Respiratory Virus ID Kit 01-120000 D3 FASTPOINT RESP VIRUS ID KIT GQS,OMG,GNS,LKT,GNY ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4,Antisera, fluoresce ANTIGENS, CF (INCLUDING CF CONTROL), PARAINFLUENZA VIRUS 1-4,Antisera, fluorescent, human metapneumovirus,ANTISERA, HAI, INFLUENZA VIRUS A, B, C,RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA,ANTISERA, FLUORESCENT, ADENOVIRUS 1-33 1 D3 Fastpoint
32 30014613311218 M121 M121 QMol HSV 1+2/VZV Control Set OHQ Multi-analyte controls unassayed 1 Quidel Molecular
33 30014613311195 M119 M119 QMol Trichomonas Control Set JJX Single (specified) analyte controls (assayed and unassayed) 1 Quidel Molecular
34 30014613311171 M117 M117 QMol Bordetella Control Set JJX Single (specified) analyte controls (assayed and unassayed) 1 Quidel Molecular
35 30014613311164 M116 M116 QMol GBS Control Set JJX Single (specified) analyte controls (assayed and unassayed) 1 Quidel Molecular
36 30014613311157 M115 M115 QMol Parainflu Control Set OHQ,JJX Multi-analyte controls unassayed,Single (specified) analyte controls (assayed an Multi-analyte controls unassayed,Single (specified) analyte controls (assayed and unassayed) 1 Quidel Molecular
37 30014613311102 M110 M110 QMol Adeno Control Set JJX Single (specified) analyte controls (assayed and unassayed) 1 Quidel Molecular
38 30014613311096 M109 M109 QMol HSV 1+2 Control Set OHQ Multi-analyte controls unassayed 1 Quidel Molecular
39 30014613311089 M108 M108 QMol CDIFF Control Set JJX Single (specified) analyte controls (assayed and unassayed) 1 Quidel Molecular
40 30014613311072 M107 M107 QMol RSV+HMPV Control Set OHQ Multi-analyte controls unassayed 1 Quidel Molecular
41 30014613311065 M106 M106 QMol FLUA+B Control Set OHQ Multi-analyte controls unassayed 1 Quidel Molecular
42 30014613311034 M103 M103 Lyra RSV+HMPV Assay OEM,OCC Human metapneumovirus (hmpv) rna assay system,Respiratory virus panel nucleic ac Human metapneumovirus (hmpv) rna assay system,Respiratory virus panel nucleic acid assay system 2 Lyra
43 30014613311003 M100 M100 Lyra FLU A+B Assay OOI,OZE,OCC real time Nucleic acid amplification system,Influenza A and influenza B multiple real time Nucleic acid amplification system,Influenza A and influenza B multiplex nucleic acid assay,Respiratory virus panel nucleic acid assay system 2 Lyra
44 30014613338703 01-00020 01-00020 CMV Antigen Control Slides LJG QUALITY CONTROL SLIDES 1 D3
45 30014613338697 01-00010 01-00010 Chlamydia Antigen Control Slides LJG QUALITY CONTROL SLIDES 1 D3
46 30014613338680 01-00070.v2 01-00070.v2 hMPV Antigen Control Slides LJG QUALITY CONTROL SLIDES 1 D3
47 30014613338673 01-00060 01-00060 VZV Antigen Control Slides LJG QUALITY CONTROL SLIDES 1 D3
48 30014613338666 01-00100 01-00100 HSV-1/HSV-2 Antigen Control Slides LJG QUALITY CONTROL SLIDES 1 D3
49 30014613338659 01-002007b 01-002007b Mounting Fluid (pH 8.0-8.4) LEB MOUNTING MEDIA 1 D3
50 30014613338642 01-014010 01-014010 Respiratory Virus Antigen Control Slides (8 well slide, 7 viruses, 1 negative well) LJG QUALITY CONTROL SLIDES 1 D3
Other products with the same Product Code "OZZ"
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 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.
3 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.
4 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.
5 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.
6 00840733102226 480750 480750 The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader, The Alethia Pertussis DNA Amplification Assay, performed on the Alethia Reader, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.The Alethia Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome. The IS481 insertional element can also be found in B. holmesii and some B. bronchiseptica strains. Respiratory infections with B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the Alethia Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Alethia Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.Alethia Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use. Alethia™ Pertussis MERIDIAN BIOSCIENCE, INC.
7 00840733102141 479930 479930 The Alethia Pertussis External Control Kit contains Positive Control Reagent for The Alethia Pertussis External Control Kit contains Positive Control Reagent for use with the Alethia Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the Alethia Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors. Alethia™ Pertussis External Control Kit MERIDIAN BIOSCIENCE, INC.
8 00840733101199 280750 280750 The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10, The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect B. pertussis by targeting the IS481 insertional element of the B. pertussis genome.Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient’s clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis MERIDIAN BIOSCIENCE, INC.
9 00840733101137 279930 279930 The illumigene Pertussis External Control Kit contains Positive Control Reagent The illumigene Pertussis External Control Kit contains Positive Control Reagent for use with the illumigene Pertussis DNA Amplification Assay. The External Positive Control Reagent is used in conjunction with the illumigene Assay Control/Negative Control reagent provided in the Pertussis kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program. illumigene Pertussis External Control Kit MERIDIAN BIOSCIENCE, INC.
10 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
11 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
12 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
13 00840487101452 50-10037 The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. ARIES® Bordetella Assay LUMINEX CORPORATION
14 00815381020161 RFIT-ASY-0130 RFIT-ASY-0130 IVD reagent kit containing 6 tests FilmArray® Respiratory Panel 2 (RP2) BIOFIRE DIAGNOSTICS, LLC
15 00815381020154 RFIT-ASY-0129 RFIT-ASY-0129 IVD reagent kit containing 30 tests FilmArray® Respiratory Panel 2 (RP2) BIOFIRE DIAGNOSTICS, LLC
16 00815381020147 RFIT-ASY-0120 RFIT-ASY-0120 IVD reagent kit containing 30 tests. FilmArray® Respiratory Panel (RP) EZ BIOFIRE DIAGNOSTICS, LLC
17 00815381020079 RFIT-ASY-0125 RFIT-ASY-0125 IVD reagent kit containing 6 tests. FilmArray® Respiratory Panel (RP) BIOFIRE DIAGNOSTICS, LLC
18 00815381020062 RFIT-ASY-0124 RFIT-ASY-0124 IVD reagent kit containing 30 tests. FilmArray® Respiratory Panel (RP) BIOFIRE DIAGNOSTICS, LLC
19 B178GBBORD100 GBBORD-10 GBBORD-10 Bordetella Direct Test Cartridge Bordetella Direct Test GREAT BASIN SCIENTIFIC, INC.
20 30014613336167 M308 M308 Solana Bordetella Complete Solana DIAGNOSTIC HYBRIDS, INC.
21 30014613312093 Bordetella Assay M209 AmpliVue Bordetella Assay AmpliVue QUIDEL CORPORATION
22 20816101025637 MOL2760 MOL2760 Simplexa™ Bordetella Positive Control Pack Simplexa™ Bordetella Positive Control Pack DIASORIN MOLECULAR LLC
23 20816101025620 MOL2750 MOL2750 Simplexa™ Bordetella Direct Simplexa™ Bordetella Direct DIASORIN MOLECULAR LLC