| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 30816101025092 | MOL1455 | OOI | Real Time Nucleic Acid Amplification System | 2 | Direct Amplification Disc Kit | ||
| 2 | 20816101025651 | MOL3560 | MOL3560 | OOI,NJR | Real Time Nucleic Acid Amplification System,Nucleic Acid Amplification Assay Sys Real Time Nucleic Acid Amplification System,Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | Simplexa™ GBS Positive Control Pack | |
| 3 | 10816101022387 | EL0928 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HerpeSelect ELISA Sample Diluent | ||
| 4 | 10816101022110 | EL0907 | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | HSV-2 ELISA IgG Cutoff Calibrator | ||
| 5 | 10816101022103 | EL0906 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 ELISA IgG Low Positive Control | ||
| 6 | 10816101022066 | EL0322 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgM Capture DxSelect™ Antigen | ||
| 7 | 10816101022059 | EL0315 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgM Capture DxSelect™ Positive Control | ||
| 8 | 30816101025085 | MOL1451 | OOI | Real Time Nucleic Acid Amplification System | 2 | Direct Amplification Disc | ||
| 9 | 10816101022165 | EL0916 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 ELISA IgG Conjugate | ||
| 10 | 20816101026962 | MOL2655 | Simplexa™ Flu A/B & RSV Direct Gen II | |||||
| 11 | 20816101025606 | MOL2960 | OZN | C.Difficile Toxin Gene Amplification Assay | 2 | Simplexa™ C. difficile Positive Control Pack | ||
| 12 | 20816101025552 | MOL2660 | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Simplexa™ Flu A/B & RSV Positive Control Pack | ||
| 13 | 20816101025507 | MOL2150 | MOL2150 | PGH | Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel | 2 | Simplexa™ HSV 1 & 2 Direct | |
| 14 | 20816101025101 | SC1100 | Simplexa™ Spectral Calibration Panel | |||||
| 15 | 10816101022356 | EL0405 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ - 10X Wash Buffer | ||
| 16 | 10816101022332 | EL0311 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control | ||
| 17 | 10816101022301 | EL0105 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ - Stop Reagent | ||
| 18 | 10816101022271 | EL0302 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgM Capture DxSelect™ Anti-Flavivirus Conjugate | ||
| 19 | 10816101022240 | EL1708 | MIZ | Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum | 2 | DxSelect™ Amber Sample Diluent | ||
| 20 | 10816101022226 | EL1608 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ Sample Diluent | ||
| 21 | 10816101022097 | EL0905 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 ELISA IgG High Positive Control | ||
| 22 | 10816101020055 | IF0951 | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Legionella IFA Substrate Slides | ||
| 23 | 20816101025583 | MOL2975 | OMN | C. Difficile Nucleic Acid Amplification Test Assay | 1 | Simplexa™ C. difficile Universal Direct | ||
| 24 | 20816101025576 | MOL2860 | PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | Simplexa™ Group A Strep Positive Control Pack | ||
| 25 | 20816101025538 | MOL2600 | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Simplexa™ Flu A/B & RSV | ||
| 26 | 20816101022155 | EL0910G-5 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HerpeSelect® 1 ELISA IgG | ||
| 27 | 20816101022148 | EL0910G | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HerpeSelect® 1 ELISA IgG | ||
| 28 | 10816101025036 | MOL1011-P | OOI | Real Time Nucleic Acid Amplification System | 2 | Integrated Cycler (220V) Pre-Owned | ||
| 29 | 10816101022349 | EL0351 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgG DxSelect™ - IgG Antigen Wells | ||
| 30 | 10816101022318 | EL0304 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgG DxSelect™ - IgG Conjugate | ||
| 31 | 10816101022295 | EL0009 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ - Substrate Reagent | ||
| 32 | 10816101022080 | EL0904 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV ELISA Negative Control | ||
| 33 | 20816101025613 | MOL5290 | OZN | C.Difficile Toxin Gene Amplification Assay | 2 | Simplexa™ C.difficile Sample Prep Kit | ||
| 34 | 20816101025569 | MOL2850 | PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | Simplexa™ Group A Strep Direct | ||
| 35 | 20816101025521 | MOL2500 | OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 2 | Simplexa™ Influenza A H1N1 (2009) | ||
| 36 | 10816101022134 | EL0909 | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | HSV-2 ELISA IgG Low Positive Control | ||
| 37 | 10816101022127 | EL0908 | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | HSV-2 ELISA IgG High Positive Control | ||
| 38 | 10816101020024 | IF0913 | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Legionella IFA Non-Detectable Control | ||
| 39 | 10816101020017 | IF0010 | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Legionella IFA Polyvalent Conjugate | ||
| 40 | 30816101025078 | MOL1401 | OOI | Real Time Nucleic Acid Amplification System | 2 | Universal Disc | ||
| 41 | 40816101025082 | MOL1451 | OOI | Real Time Nucleic Acid Amplification System | 2 | Direct Amplification Disc | ||
| 42 | 40816101025075 | MOL1400 | OOI | Real Time Nucleic Acid Amplification System | 2 | Universal Disc | ||
| 43 | 20816101025774 | MOL3650 | PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | 2 | Simplexa™ VZV Direct | ||
| 44 | 20816101025545 | MOL2650 | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Simplexa™ Flu A/B & RSV Direct | ||
| 45 | 10816101025005 | MOL1001 | OOI | Real Time Nucleic Acid Amplification System | 2 | Integrated Cyler (110V) | ||
| 46 | 10816101022363 | EL0901 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 IgG Antigen Wells | ||
| 47 | 10816101022288 | EL0303 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgM Capture DxSelect™ IgM Cutoff Calibrator (0.3 mL) | ||
| 48 | 10816101022172 | EL0917 | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | HSV-2 ELISA IgG Conjugate | ||
| 49 | 10816101022073 | EL0903 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 ELISA IgG Cutoff Calibrator | ||
| 50 | 10816101021038 | IB0910 | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | HSV-1 and HSV-2 Immunoblot IgG Negative Control |
| 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 |