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 Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD 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

• 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
• 00840487101766 - VERIGENE® II System: 2019-12-25 The VERIGENE® II System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratorie
• 00840487101773 - VERIGENE® II Module: 2019-12-25 The VERIGENE® II Module is a component of the VERGIENE® II System. When installed in the VERIGENE® II System it is capable o
• 00840487101445 - ARIES® MRSA Assay: 2019-10-16 The ARIES® MRSA Assay is an integrated real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for
• 00840487100059 - ARIES® C. difficile Assay: 2018-07-06 The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the
• 00840487100073 - ARIES® Extraction Kit: 2018-07-06 The ARIES® Extraction Kit is intended to extract nucleic acid from human biological specimens and universal transport media (UT