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 Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory Multiplex analyser IVD, laboratory| 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
| 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 |
Trademark Results [FLEXMAP 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLEXMAP 3D 77237943 3686642 Live/Registered |
Luminex Corporation 2007-07-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.