Address:3471 River Hills Dr,CINCINNATI,OH,45244,US
Device Description : MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofl MERIFLUOR Cryptosporidium/Giardia (MERIFLUOR C/G) is an in vitro direct immunofluorescent detection procedure for the simultaneous detection of Cryptosporidium oocysts and Giardia cysts in fecal material.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The illumigene C. difficile External Control Kit contains Positive and Negative The illumigene C. difficile External Control Kit contains Positive and Negative Control Reagents for use with the illumigene C. difficile test kit. External controls are used as part of a routine quality control program.
Device Class : 1
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The illumigene Mycoplasma External Control Kit contains Positive and Negative Co The illumigene Mycoplasma External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Mycoplasma test kit. External controls are used as part of a routine quality control program. External controls are used as part of a routine quality control program.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The illumigene HSV 1&2 External Control Kit contains Positive and Negative Contr The illumigene HSV 1&2 External Control Kit contains Positive and Negative Control Reagents for use with the illumigene HSV 1&2 DNA Amplification Assay. External controls are used as part of a routine quality control program.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The illumigene C. difficile DNA amplification assay, performed on the illumipro- The illumigene C. difficile DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of toxigenic C. difficile in human stool specimens from pediatric and adult patients suspected of having Clostridium difficile-associated disease (CDAD).The illumigene C. difficile assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect the pathogenicity locus (PaLoc) of toxigenic Clostridium difficile. The Clostridium difficile PaLoc is a gene segment present in all known toxigenic C. difficile strains. The C. difficile PaLoc codes for both the Toxin A gene (tcdA) and the Toxin B gene (tcdB), has conserved border regions, and is found at the same site on the C. difficile genome for all toxigenic strains. The illumigene C. difficile assay detects the PaLoc by targeting a partial DNA fragment on the Toxin A gene. The tcdA target region was selected as an intact region remaining in all known A+B+ and A-B+ toxinotypes.
Device Class : 1
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : "The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-1 "The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the illumigene Mycoplasma DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10, i The illumigene HSV 1&2 DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) DNA in cutaneous and mucocutaneous lesion specimens from male and female patients suspected of Herpetic infections. illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect HSV-1 and HSV-2 by targeting segments of the herpes simplex virus 1 and herpes simplex virus 2 genomes. Results from illumigene HSV 1&2 are used as an aid in the diagnosis of HSV infection in symptomatic patients.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : 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.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : MERIFLUOR Chlamydia is an in vitro direct immunofluorescent detection procedure MERIFLUOR Chlamydia is an in vitro direct immunofluorescent detection procedure for the detection of Chlamydia trachomatis and Chlamydia psittaci in McCoy cells
Device Class : 1
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes