ARIES MRSA Assay
K-Number: K191742 · 2019-09-25
ApplicantLuminex Corporation
Decision Date2019-09-25
Product CodeNQX
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
ARIES MRSA Assay is a medical device manufactured by Luminex Corporation. It received FDA 510(k) clearance on 2019-09-25 under approval number K191742. The device is classified under product code NQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ARIES MRSA Assay?
ARIES MRSA Assay is a medical device that received FDA 510(k) clearance on 2019-09-25. It is manufactured by Luminex Corporation. The 510(k) number is K191742.
When was ARIES MRSA Assay approved by the FDA?
ARIES MRSA Assay received FDA 510(k) clearance on 2019-09-25, under approval number K191742.
What company makes ARIES MRSA Assay?
ARIES MRSA Assay is manufactured by Luminex Corporation.
What is the FDA product code for ARIES MRSA Assay?
The FDA product code for ARIES MRSA Assay is NQX.
Other Devices by Luminex Corporation
K162772ARIES GBS Assay
K161220ARIES® Flu A/B & RSV Assay
K161495ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
K160517ARIES System
K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
Related Devices (Code: NQX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.