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 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| info@luminexcorp.com | |
| Phone | +1(512)219-8020 |
| 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
| 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 |
Trademark Results [SYNCT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNCT 88608087 not registered Live/Pending |
Palacios, Steven T 2019-09-06 |
 SYNCT 88010252 5869453 Live/Registered |
ARSENAL CYCLING LLC 2018-06-21 |
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