SYNCT™ Software

GUDID 00840487100448

The SYNCT Software is a desktop application that can be utilized by an end-user on a standalone computer, providing users the ability to operate general functions such as Order Management, with or without a Laboratory Information System (LIS), viewing test results, reviewing and preparing test reports, performing software administrative functions, and providing security control for permitted functions.

LUMINEX CORPORATION

Laboratory instrument/analyser application software IVD

• Primary Device ID: 00840487100448
• NIH Device Record Key: 8d308d2e-9be3-4241-9f81-e7b03f40f207
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNCT™ Software
• Version Model Number: CN-SW47
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com
• Phone: +1(512)219-8020
• Email: info@luminexcorp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487100448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152386

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

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• 00840487101841 - LIAISON PLEX Gram-Negative Blood Culture Assay: 2025-06-19 The LIAISON PLEX® Gram-Negative Blood Culture (BCN) Assay, performed using the automated, sample-to-result LIAISON PLEX® Syste
• 00840487101865 - LIAISON PLEX Yeast Blood Culture Assay Kit: 2024-10-30 The LIAISON PLEX® Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for
• 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