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Device Description : MERIFLUOR VZV is an in vitro direct immunofluorescent detection procedure for th MERIFLUOR VZV is an in vitro direct immunofluorescent detection procedure for the detection of varicella-zoster virus (VZV) in vesicle smears and biopsy specimens. in addition, the reagent can be used to confirm the presence of VZV in cell culture.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The PREMIERCryptococcal Antigen enzyme immunoassay (EIA) is a screening or a sem The PREMIERCryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrospinal fluid (CSF).
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The PREMIER Coccidioides enzyme immunoassay (EIA) is for the qualitative detecti The PREMIER Coccidioides enzyme immunoassay (EIA) is for the qualitative detection of IgM and IgG antibodies directed against the TP and CF antigens of Coccidioides immitis in serum and cerebrospinal fluid (CSF).
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The illumipro-10 is an automated isothermal amplification and detection system f The illumipro-10 is an automated isothermal amplification and detection system for use with Meridian Bioscience, Inc. illumigene Loop-Mediated Amplification products.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : Para-Pak Systems provide standardized procedures for the routine collection, tra Para-Pak Systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transport.
Device Class : 1
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. It is designed to test specimens from patients with symptoms of pneumonia.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : The illumigene Mycoplasma Direct DNA amplification assay, performed on the illum The illumigene Mycoplasma Direct 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 swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma Direct 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 Direct 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 Mycoplasma Direct External Control Kit contains Positive Control The illumigene Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the illumigene Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent provided with the illumigene Mycoplasma Direct 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 : MONOSPOT Latex is a one step rapid latex particle agglutination test for the qua MONOSPOT Latex is a one step rapid latex particle agglutination test for the qualitative and semiquantitative determination of infectious mononucleosis heterophile antibodies in serum or plasma.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes
Device Description : GullSORB is an antihuman IgG reagent used to eliminate IgG interference in human GullSORB is an antihuman IgG reagent used to eliminate IgG interference in human serum containing both IgM and IgG. This reagent has been standardized for use with IgM IFA assays manufactured by Meridian Bioscience, Inc.
Device Class : 2
Duns Number: 092815364
Premarket Exempt : No
Prescription Use : Yes