Address:4088 Commercial Avenue,Northbrook,IL,60062,US
Device Description : Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
Device Class : 1
Duns Number: 079686463
Premarket Exempt : Yes
Prescription Use : No
Device Description : Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
Device Class : 1
Duns Number: 079686463
Premarket Exempt : Yes
Prescription Use : No
Device Description : Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
Device Class : 1
Duns Number: 079686463
Premarket Exempt : Yes
Prescription Use : No
Device Description : Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
Device Class : 1
Duns Number: 079686463
Premarket Exempt : Yes
Prescription Use : No
Device Description : Nucleic acid sequences, which, through specific binding or chemical reaction wit Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
Device Class : 1
Duns Number: 079686463
Premarket Exempt : Yes
Prescription Use : No
Device Description : The MAGPIX system is a multiplex test system intended to measure and sort multip The MAGPIX system is a multiplex test system intended to measure and sort multiple signals generated in an assay from a sample. The system includes a signal reader unit, raw data storage mechanisms, data acquisition software to process detected signals and system reagents. The MAGPIX platform is intended for use in a Clinical Diagnostic laboratory. The system will be used for protein expression and nucleic acidapplications.
Device Class : 2
Duns Number: 965476641
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Luminex MAGPIX Calibration Kit is intended to calibrate the optics of the MA The Luminex MAGPIX Calibration Kit is intended to calibrate the optics of the MAGPIX instrument. During calibration, the system adjusts LED current and calibration factors for CL1, CL2, and RP1 until those values match the imported target values, thus calibrating the classification map.
Device Class : 2
Duns Number: 965476641
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Luminex MAGPIX Performance Verification Kit is intended to verify the optica The Luminex MAGPIX Performance Verification Kit is intended to verify the optical calibration of the MAGPIX instrument.
Device Class : 2
Duns Number: 965476641
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ARIES® HSV 1 & 2 Assay is a polymerase chain reaction (PCR)-based qualitativ The ARIES® HSV 1 & 2 Assay is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the direct detection and differentiation of herpes simplex virus (HSV) DNA from cutaneous and mucocutaneous lesion swab specimens.
Device Class : 2
Duns Number: 965476641
Premarket Exempt : No
Prescription Use : Yes
Device Description : The FLEXMAP 3D® system is a compact analyzer that performs up to 500 analytes fr The FLEXMAP 3D® system is a compact analyzer that performs up to 500 analytes from a single sample. The instrument includes four subsystems: electronic, fluidic, mechanical, and optical; and utilizes xPONENT®software version 4.0 SP1 of the xMAP® (Multi-Analyte Profiling) technology operating system. The electronics system provides the power for operation and control of the FLEXMAP 3D system and communication between its parts. The fluidics system handles the flow of liquid through the Luminex® FLEXMAP 3D® instrument. The mechanical subsystem of the Luminex® FLEXMAP 3D® instrument includes a filter system used to aid in cooling of the instrument and pressurized sheath fluid. The optical sub-system consists of the optical assembly and excitation lasers and does not require manual adjustment by the user
Device Class : 2
Duns Number: 965476641
Premarket Exempt : No
Prescription Use : Yes