Luminex Corporation - FDA 510(k) Cleared Devices

Cleared Jun 06, 2025

LIAISON PLEX Gram-Positive Blood Culture Assay

K243490 · PAM

Microbiology · 206d

Cleared Apr 18, 2025

LIAISON PLEX Gram-Negative Blood Culture Assay

K243013 · PEN

Microbiology · 203d

Cleared Jun 04, 2024

LIAISON PLEX Yeast Blood Culture Assay

K240627 · PEO

Microbiology · 90d

Cleared Mar 01, 2024

LIAISON PLEX Respiratory Flex Assay

K233410 · QOF

Microbiology · 147d

Cleared Sep 25, 2019

ARIES MRSA Assay

K191742 · NQX

Microbiology · 86d

Cleared Oct 30, 2017

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

K172402 · PGX

Microbiology · 82d

Cleared Jul 21, 2017

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File...

K171441 · OZN

Microbiology · 66d

Cleared May 02, 2017

ARIES Bordetella Assay

K163626 · OZZ

Microbiology · 131d

Cleared Dec 23, 2016

ARIES GBS Assay

K162772 · NJR

Microbiology · 81d

Cleared Aug 02, 2016

ARIES® Flu A/B & RSV Assay

K161220 · OCC

Microbiology · 95d

Cleared Jun 30, 2016

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV...

K161495 · OOI

Microbiology · 29d

Cleared Apr 12, 2016

ARIES System

K160517 · OOI

Microbiology · 48d