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Device Description : Curian is an Immunoassay Analyzer designed to automate incubation, results inter Curian is an Immunoassay Analyzer designed to automate incubation, results interpretation and results reporting of immunoassay diagnostic products. Curian is intended for use with Curian fluorescent immunoassay products. Curian-compatible Meridian Bioscience products are described in individual immunoassay package inserts.
Device Class : 1
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in t The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment is used at least 4 weeks following completion of therapy. For there purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ration of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by the heath care professional, as ordered by a licensed health care practitioner.
Device Class :
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The web based application for calculation pediatric urea hydrolysis rate as part The web based application for calculation pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
Device Class : 3
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : Nasopharyngeal Wash/Aspirate Kit for use with ImmunoCard STAT! FLU A&B. ImmunoCa Nasopharyngeal Wash/Aspirate Kit for use with ImmunoCard STAT! FLU A&B. ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.Moderate Complexity when used with Nasal Wash/Aspirate Samples.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects infl ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.Moderate Complexity when used with Nasal Wash/Aspirate Samples. CLIA Waived when used with Nasal and Nasopharyngeal Swabs.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : Alethia™ is an automated isothermal amplification and detection system for use w Alethia™ is an automated isothermal amplification and detection system for use with Meridian Bioscience, Inc.’s Alethia Loop-Mediated Amplification assays.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitati The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post-therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.
Device Class : 1
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to d Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from symptomatic patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.
Device Class : 1
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clos Premier Toxins A&B is a qualitative enzyme immunoassay for the detection of Clostridium difficile toxin A and toxin B in stool from patients with antibiotic-associated diarrhea. Premier Toxins A&B is intended for use as an aid in the diagnosis of C. difficile associated disease (CDAD).
Device Class : 1
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : Premier Rotaclone is an Enzyme Immunoassay (EIA) intended for the detection of r Premier Rotaclone is an Enzyme Immunoassay (EIA) intended for the detection of rotavirus antigen in human fecal specimens.
Device Class : 1
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes