Top News
Home >> Tag Archives: Luminex

Tag Archives: Luminex

FDA-cleared Bordetella assay, 8/17

August 2017—Luminex received FDA clearance for the Aries Bordetella Assay for direct detection and identification of Bordetella pertussis and Bordetella parapertussis nucleic acid in nasopharyngeal swab specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.

Read More »

FDA clearance for Aries Bordetella assay

June 5, 2017—Luminex received FDA clearance for the Aries Bordetella Assay for direct detection and identification of Bordetella pertussis and Bordetella parapertussis nucleic acid in nasopharyngeal swab specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis. The company has also achieved CE-IVD marking for the Aries Bordetella Assay, is preparing to submit ...

Read More »

Luminex’s molecular test for flu A/B, RSV cleared

Aug. 23, 2016—Luminex has received FDA clearance for the Aries Flu A/B and RSV Assay. This is the second assay the FDA has cleared for use on the Luminex Aries system. The Aries Flu A/B and RSV Assay delivers results in less than two hours for the detection and differentiation of three key respiratory pathogens (influenza A virus, influenza B ...

Read More »

Luminex lands EUA for molecular Zika test

Aug. 17, 2016—Luminex has received emergency use authorization from the FDA for a multiplex nucleic acid test designed to detect Zika virus RNA in potentially infected patients using their blood serum, plasma, or urine (collected alongside a patient-matched serum or plasma specimen). The test is called the xMap MultiFlex Zika RNA Assay, designed by Luminex partner GenArraytion Inc. In July ...

Read More »

FDA clearance, CE mark for Luminex Aries M1

July 11, 2016—Luminex has received FDA clearance and CE-IVD marking for a new in vitro diagnostic system, the Aries M1. Designed for lower throughput clinical labs, the Aries M1 System is a fully integrated, sample-to-answer platform for performing real-time PCR assays. The Aries M1 is designed to empower satellite clinical laboratories to take advantage of the same benefits as Luminex’s ...

Read More »

Luminex lands FDA clearance for respiratory panel

Dec. 21, 2015—Luminex has received FDA clearance for its NxTag Respiratory Pathogen Panel that detects 20 clinically relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae and Mycoplasma pneumonia. The respiratory assay panel is designed to enable laboratories to easily and simultaneously detect 20 respiratory pathogens in a single closed-tube system in a format that scales to ...

Read More »
X