Luminex® 100/200™

GUDID 00840487100110

The Luminex 100/200 System is a compact analyzer that performs up to 100 bioassays simultaneously, using a single drop of fluid therefore requiring very small patient samples.

LUMINEX CORPORATION

Multiplex analyser IVD, laboratory, semi-automated

• Primary Device ID: 00840487100110
• NIH Device Record Key: 2c5e2912-66f0-4c35-b147-c07bc85c0b3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminex® 100/200™
• Version Model Number: Luminex 100/200
• 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
• 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	00840487100110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073506

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.