FLEXMAP 3D®

GUDID 00840487100301

The FLEXMAP 3D® system is a compact analyzer that performs up to 500 analytes from a single sample. The instrument includes four subsystems: electronic, fluidic, mechanical, and optical; and utilizes xPONENT® software version 4.0 SP1 of the xMAP® (Multi-Analyte Profiling) technology operating system. The electronics system provides the power for operation and control of the FLEXMAP 3D system and communication between its parts. The fluidics system handles the flow of liquid through the Luminex® FLEXMAP 3D® instrument. The mechanical subsystem of the Luminex® FLEXMAP 3D® instrument includes a filter system used to aid in cooling of the instrument and pressurized sheath fluid. The optical sub-system consists of the optical assembly and excitation lasers and does not require manual adjustment by the user

LUMINEX CORPORATION

Multiplex analyser IVD, laboratory, semi-automated

• Primary Device ID: 00840487100301
• NIH Device Record Key: 9d7bc92d-dad5-4f5e-a88d-019e7ea239e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEXMAP 3D®
• Version Model Number: FLEXMAP 3D
• 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	00840487100301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121399

FDA Product Code

• NSU: Instrumentation for clinical multiplex test systems

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

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• 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.