FLEXMAP 3D® Calibration Kit
GUDID 00840487100363
The Luminex® FLEXMAP 3D® Calibration Kit contains all reagents needed for 25 calibrations of the FLEXMAP 3D® platform with Luminex® xPONENT® software.
LUMINEX CORPORATION
Multiplex analyser IVD, laboratory, semi-automated| Primary Device ID | 00840487100363 |
| NIH Device Record Key | 060db2f0-5f6d-4074-b370-8648f6af88f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FLEXMAP 3D® Calibration Kit |
| Version Model Number | F3DIVD-CAL-K25 |
| 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 | true |
| 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 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com | |
| Phone | +1(512)381-4397 |
| support@luminexcorp.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840487100363 [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
| 00840487101858 - LIAISON PLEX Gram-Positive Blood Culture Assay | 2025-07-21 The LIAISON PLEX® Gram-Positive Blood Culture (BCP) Assay, performed using the automated, sample-to-result LIAISON PLEX® Syste |
| 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 |
Trademark Results [FLEXMAP 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLEXMAP 3D 77237943 3686642 Live/Registered |
Luminex Corporation 2007-07-25 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.