For the direct quantitative determination of DHEAS by an enzyme immunoassay in human serum.

For the quantitative determination of Estrone in human saliva by a chemiluminescence immunoassay.

For the Quantitative Determination of Follicle Stimulating Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay, Colorimetric.

The Quantitative Determination of Luteinizing Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay, Colorimetric.

The Quantitative Determination of Free Triiodothyronine Concentration in Human Serum by a Microplate Enzyme Immunoassay.

The Quantitative Determination of Free Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay.

The Quantitative Determination of Thyrotropin Concentration in Human Serum by a Microplate Immunoenzymometric assay.

For the direct quantitative determination of Pregnenolone by enzyme immunoassay in human serum.

The Quantitative Determination of Free Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay.

For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human serum. For in vitro diagnostic use only.

For the direct quantitative determination of Pregnenolone by an enzyme immunoassay in human serum.

The measurement of the total amount of binding sites available for the Thyroid Hormones in human serum or plasma by a microplate enzyme Immunoassay.

The Quantitative Determination of Free Triiodothyronine Concentration in Human Serum by a Microplate Enzyme Immunoassay.

The device is an Enzyme Immunoassay (EIA) for the quantitative measurement of free testosterone in human serum. s and adrogenital syndromes.

The Verigene® Reader is the central control of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

Sheath fluid is the delivery medium of the sample to the optics component.

A concentrated version of xMAP® Sheath Fluid, when diluted is is the delivery medium of the sample to the optics component.

The ARIES® Extraction Kit is intended to extract nucleic acid from human biological specimens and universal transport media (UTM).

The ARIES® M1 System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay.

The SYNCT Software is a desktop application that can be utilized by an end-user on a standalone computer, providing users the ability to operate general functions such as Order Management, with or without a Laboratory Information System (LIS), viewing test results, reviewing and preparing test reports, performing software administrative functions, and providing security control for permitted functions.

The Luminex® FLEXMAP 3D® Calibration Kit contains all reagents needed for 25 calibrations of the FLEXMAP 3D® platform with Luminex® xPONENT® software.

The Luminex® FLEXMAP 3D® Performance Verification Kit is used to run performance verification on the FLEXMAP 3D analyzer. The Luminex FLEXMAP 3D® Performance Verification Kit includes sufficient reagents to perform 25 verifications of the calibration and optical integrity for the Luminex FLEXMAP 3D® System.

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

The Luminex 100/200 System is a compact analyzer that performs up to 100 bioassays simultaneously, using a single drop of fluid therefore requiring very small patient samples.

xMAP Calibrator Microspheres, Classification (CAL1) and Reporter (CAL2), are polystyrene microspheres that are internally labeled with fluorescent dyes. They serve as system calibrators for Luminex xMAP technology based detectors and are intended to normalize the settings for both the classification channel (CL1, CL2), the doublet discriminator channel (DD), and the reporter channel (RP1).

xMAP Control Microspheres, Classification (CON1) and Reporter (CON2), are polystyrene microspheres that are internally labeled with fluorescent dyes. The control microspheres are intended to verify the calibration and optical integrity for the Luminex 100/200 System. Classification Control Microspheres verify both classification channels and the doublet discriminator channel (DD). Reporter Control Microspheres verify the reporter channel.

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.

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.

The Luminex MAGPIX Performance Verification Kit is intended to verify the optical calibration of the MAGPIX instrument.

The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections.

The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and identification of nucleic acids from multiple gastroenteritis causing viruses, parasites and bacteria (including toxin gene detection) in human stool samples that are fresh, frozen or in a holding medium, from individuals with signs and symptoms of infectious colitis or gastroenteritis.

The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection.