No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 30014613336754 | RPS-ID-20-U | RPS-ID-20-U | InflammaDry | GOD | ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33 | 1 | InflammaDry |
2 | 30014613336747 | RPS-ID-20 | RPS-ID-20 | InflammaDry | PFQ,JJX | MMP-9 test system,Single (specified) analyte controls (assayed and unassayed) | 1 | InflammaDry |
3 | 30014613336402 | Trichomonas Assay | M304.U | SolanaTrichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | Solana |
4 | 30014613336396 | Trichomonas Assay | M304.S | Solana Trichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | Solana |
5 | 30014613336082 | Group A Strep Assay | M301 | Solana GAS Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | Solana |
6 | 30014613335580 | C1-Inhibitor | A037 | MicroVue C1-Inhibitor Plus EIA | DBA | COMPLEMENT C1 INHIBITOR (INACTIVATOR), ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
7 | 30014613335573 | Bp Plus EIA | A027 | Kit, Quidel Bb Plus | JZH | FACTOR B, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
8 | 30014613335566 | CH50 Eq EIA | A018 | MicroVue CH50 Eq EIA | DAE | COMPLEMENT C9, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
9 | 30014613335559 | CIC-C1q Controls | A013 | MicroVue CIC-C1q Ctrls | DAK | COMPLEMENT C1Q, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
10 | 30014613335542 | CIC-Raji EIA | A002 | MicroVue CIC-Raji EIA | CZY | COMPLEMENT C1S, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
11 | 30014613335535 | CIC-C1q EIA | A001 | MicroVue CIC-C1q EIA | DAK | COMPLEMENT C1Q, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
12 | 30014613333951 | Vitamin D EIA | 8046 | MicroVue Vitamin D EIA | MRG | SYSTEM, TEST, VITAMIN D | 2 | MicroVue |
13 | 30014613333944 | PTH EIA | 8044 | MicroVue PTH EIA | CEW | RADIOIMMUNOASSAY, PARATHYROID HORMONE | 2 | MicroVue |
14 | 30014613333937 | Calcitonin EIA | 8043 | MicroVue Calcitonin EIA | JKR | RADIOIMMUNOASSAY, CALCITONIN | 2 | MicroVue |
15 | 30014613333920 | BAP EIA | 8012 | MicroVue BAP EIA | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | MicroVue |
16 | 30014613333913 | PYD EIA | 8010 | Kit, McVu PYD | JMM | COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE | 1 | MicroVue |
17 | 30014613333906 | DPD EIA | 8007 | Kit, McVu DPD | JMM | COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE | 1 | MicroVue |
18 | 30014613311140 | Parainfluenza Virus Assay | M114 | Lyra Parainfluenza Assay | OOU | Parainfluenza multiplex nucleic acid assay | 2 | Lyra |
19 | 30014613311133 | Adenovirus Assay | M113 | Lyra Adenovirus Assay | OCC | Respiratory virus panel nucleic acid assay system | 2 | Lyra |
20 | 30014613311126 | Direct Strep Assay | M112 | Lyra Direct Strep Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | Lyra |
21 | 30014613311058 | Direct C. difficile Assay | M105 | Lyra Direct CDIFF Assay | OZN,OOI | C.Difficile toxin gene amplification assay,real time Nucleic acid amplification system | 2 | Lyra |
22 | 30014613311027 | Direct HSV 1+2/VZV Assay | M102 | Lyra Direct 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 | Lyra |
23 | 30014613202783 | 20278 | 20278 | Solana instrument | NSU | Instrumentation for clinical multiplex test systems | 2 | Solana |
24 | 30014613003458 | 00345 | 00345 | QkVue InLine Strep A Ctrl Set | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue In-Line |
25 | 30014613003434 | 00343 | 00343 | QkVue InLine Strep A 25T | GTZ | ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue In-Line |
26 | 30014613336686 | RPS-AD | RPS-AD | AdenoPlus | GOD | ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33 | 1 | AdenoPlus |
27 | 30014613339724 | 20402 | 20402 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
28 | 30014613339687 | 20399 | 20399 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
29 | 30014613339670 | 20398 | 20398 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
30 | 30014613339373 | 20387 | 20387 | QuickVue® SARS Antigen Test | QuickVue | |||
31 | 30014613331469 | 20189 | 20189 | QkVue Flu A+B 20K-T, Bulk | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
32 | 30014613331452 | 20163 | 20163 | QkVue Strep A Dpstk, 4T Samp | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
33 | 30014613320104 | 0W010 | 0W010 | QkVue H pylori gII 30T | LYR | Helicobacter pylori | 1 | QuickVue |
34 | 30014613320098 | 0W009 | 0W009 | QkVue H pylori gII 10T | LYR | Helicobacter pylori | 1 | QuickVue |
35 | 30014613312123 | Group A Strep Assay | M212 | AmpliVue GAS Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | AmpliVue |
36 | 30014613312116 | Trichomonas Assay | M211 | AmpliVue Trichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | AmpliVue |
37 | 30014613312109 | HSV 1+2 Assay | M210 | AmpliVue HSV 1+2 Assay | OQO | Herpes simplex virus nucleic acid amplification assay | 2 | AmpliVue |
38 | 30014613312024 | GBS Assay | M202 | AmpliVue GBS Assay | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | AmpliVue |
39 | 30014613312017 | C. difficile Assay | M201 | AmpliVue CDiff Assay | OZN | C.Difficile toxin gene amplification assay | 2 | AmpliVue |
40 | 30014613202226 | 20222 | 20222 | QkVue RSV 10, 25T | GQG | ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 1 | QuickVue |
41 | 30014613202059 | iFOB Test | 20205 | QuickVue iFOB Test Dev Kit 100T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
42 | 30014613202042 | iFOB Test | 20204 | QuickVue iFOB Collect Kit 40T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
43 | 30014613202011 | iFOB Test | 20201 | QuickVue iFOB Tray Pack 50T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
44 | 30014613201977 | 20197 | 20197 | QkVue iFOB Control Set | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
45 | 30014613201960 | iFOB Test | 20196 | QuickVue iFOB Collect Kit 10T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
46 | 30014613201946 | iFOB Test | 20194 | QuickVue iFOB 20T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
47 | 30014613201939 | 20193 | 20193 | QkVue RSV 20T | MCE,GQG | RESPIRATORY SYNCYTIAL VIRUS - ELISA,ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRA RESPIRATORY SYNCYTIAL VIRUS - ELISA,ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 1 | QuickVue |
48 | 30014613201830 | 20183 | 20183 | QkVue Flu A+B 25T, CE | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
49 | 30014613201526 | 20152 | 20152 | QkVue Strep A Dpstk 10T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
50 | 30014613201250 | 20125 | 20125 | QkVue Strep A Dpstk 25T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
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 |