ARIES® System

GUDID 00840487101537

The ARIES® System is a clinical multiplex test system that automates and integrates extraction of nucleic acid from a clinical sample, performs real -time PCR, and measuring and sorting multiple signals generated in an in vitro diagnostic assay.

LUMINEX CORPORATION

Multiplex analyser IVD, laboratory, semi-automated

• Primary Device ID: 00840487101537
• NIH Device Record Key: 1734cb34-652c-46ed-9747-c8ad1eeb670a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIES® System
• Version Model Number: ARIES M12V1
• Company DUNS: 965476641
• Company Name: LUMINEX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com
• Phone: +1(512)381-4397
• Email: support@luminexcorp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487101537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151906

FDA Product Code

• OOI: real time Nucleic acid amplification system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-09

Devices Manufactured by LUMINEX CORPORATION

• 00840487101940 - LIAISON PLEX® Respiratory Flex Assay Kit: 2024-06-28 The LIAISON PLEX® Respiratory Flex (RSP Flex) Assay is a multiplexed qualitative test for the simultaneous in vitro detection a
• 00840487101957 - LIAISON PLEX® Chassis: 2024-06-28 The LIAISON PLEX® is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The
• 00840487101964 - LIAISON PLEX® Chassis (Refurbished): 2024-06-28 The LIAISON PLEX® is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The
• 00840487101971 - LIAISON PLEX® Module: 2024-06-28 The LIAISON PLEX® Module is a component of the LIAISON PLEX® Chassis. When installed in the LIAISON PLEX® Chassis it is capa
• 00840487101988 - LIAISON PLEX® Module (Refurbished): 2024-06-28 The LIAISON PLEX® Module is a component of the LIAISON PLEX® Chassis. When installed in the LIAISON PLEX® Chassis it is capa
• 00840487101797 - MAGPIX® Drive Fluid PLUS (4PK): 2022-09-16 The MAGPIX Drive Fluid PLUS serves as the delivery medium that carries the sample to the optics component of the MAGPIX instrume
• 00840487101803 - xMAP® Sheath Fluid PLUS: 2022-09-16 Sheath Fluid PLUS is the delivery medium of the sample to the optics component.
• 00840487101780 - xMAP® Sheath Concentrate PLUS: 2021-03-08 A concentrated version of xMAP® Sheath Fluid PLUS, when diluted is is the delivery medium of the sample to the optics component