Address:12212 Technology Blvd,AUSTIN,TX,78727,US
Device Description : The Verigene® Reader is the central control of the Verigene® System, a benchtop 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.
Device Class : 2
Duns Number: 080778937
Premarket Exempt : No
Prescription Use : Yes
Device Description : xMAP Control Microspheres, Classification (CON1) and Reporter (CON2), are polyst 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.
Device Class : 2
Duns Number: 965476641
Premarket Exempt : No
Prescription Use : Yes
Device Description : xMAP Calibrator Microspheres, Classification (CAL1) and Reporter (CAL2), are pol 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).
Device Class : 2
Duns Number: 965476641
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Luminex® FLEXMAP 3D® Performance Verification Kit is used to run performance 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.
Device Class : 2
Duns Number: 965476641
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Luminex® FLEXMAP 3D® Calibration Kit contains all reagents needed for 25 cal The Luminex® FLEXMAP 3D® Calibration Kit contains all reagents needed for 25 calibrations of the FLEXMAP 3D® platform with Luminex® xPONENT® software.
Device Class : 2
Duns Number: 965476641
Premarket Exempt : No
Prescription Use : Yes
Device Description : The SYNCT Software is a desktop application that can be utilized by an end-user 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.
Device Class : 2
Duns Number: 965476641
Premarket Exempt : No
Prescription Use : Yes
Device Description : The MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit is a polymerase chain reaction The MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit is a polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV 1 & 2) DNA in vaginal lesions. It is indicated for use in the detection and typing of HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients as an aid in the diagnosis of genital herpes infection.
Device Class : 2
Duns Number: 079686463
Premarket Exempt : No
Prescription Use : Yes
Device Description : Internal control used in real-time polymerase chain reaction (pcr) assays to det 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.
Device Class : 1
Duns Number: 079686463
Premarket Exempt : Yes
Prescription Use : No
Device Description : Internal control used in real-time polymerase chain reaction (pcr) assays to det 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.
Device Class : 1
Duns Number: 079686463
Premarket Exempt : Yes
Prescription Use : No
Device Description : Internal control used in real-time polymerase chain reaction (pcr) assays to det 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.
Device Class : 1
Duns Number: 079686463
Premarket Exempt : Yes
Prescription Use : No