Luminex Corporation - FDA 510(k) Cleared Devices
14
Total
14
Cleared
0
Denied
Luminex Corporation has 14 FDA 510(k) cleared microbiology devices. Based in Austin, US.
Latest FDA clearance: Jun 2025. Active since 2015.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Luminex Corporation
14 devices
Cleared
Jun 06, 2025
LIAISON PLEX Gram-Positive Blood Culture Assay
Microbiology
206d
Cleared
Apr 18, 2025
LIAISON PLEX Gram-Negative Blood Culture Assay
Microbiology
203d
Cleared
Jun 04, 2024
LIAISON PLEX Yeast Blood Culture Assay
Microbiology
90d
Cleared
Mar 01, 2024
LIAISON PLEX Respiratory Flex Assay
Microbiology
147d
Cleared
Sep 25, 2019
ARIES MRSA Assay
Microbiology
86d
Cleared
Oct 30, 2017
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
Microbiology
82d
Cleared
Jul 21, 2017
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File...
Microbiology
66d
Cleared
May 02, 2017
ARIES Bordetella Assay
Microbiology
131d
Cleared
Dec 23, 2016
ARIES GBS Assay
Microbiology
81d
Cleared
Aug 02, 2016
ARIES® Flu A/B & RSV Assay
Microbiology
95d
Cleared
Jun 30, 2016
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV...
Microbiology
29d
Cleared
Apr 12, 2016
ARIES System
Microbiology
48d