Alinity m HCV Application Specification File

A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.

A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.

A rapid, automated, molecular test for the qualitative detection of Streptococcus pyogenes Group A bacterial nucleic acid in throat swab specimens.

The Alere™ i Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Alere molecular diagnostic assays.

The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays.

The Alere™ i Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Alere molecular diagnostic assays.

The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays.

KIT PREWARM MAX6

Kit Vaginal Reagent COR IVD

Kit BD MAX CPO

IVD reagent kit containing 30 tests.

GENEXPERT Xpress System

The GenXplore® system is an automated qPCR-based nucleic acid testing system. It can perform nucleic acid extraction, liquid handling, thermal cycling, and real-time fluorescence detection for testing nucleic acids from human samples, specifically for in vitro diagnostic purposes. The GenXplore® system is intended for professional use only and indoor use only.

The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes.This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel.

The QIAstat-Dx Analyzer 2.0 platform is intended as an in vitro diagnostic device for use with QIAstat-Dx assays and provides full automation from sample preparation to real-time PCR detection for molecular applications.

Q Station™ Dx 1000

Q Station™ Dx 1000

The RIDA®GENE Norovirus GI/GII assay, performed on the Applied Biosystems® 7500 Fast Dx System, is a real-time RT-PCR in vitro diagnostic test for the qualitative detection and differentiation of norovirus genogroup I (GI) and II (GII) RNA from raw or unpreserved stool specimens collected from individuals with signs and symptoms of acute gastroenteritis.