Primary Device ID | 00840487101766 |
NIH Device Record Key | edcf186d-0f91-4f2d-918a-e3bc3c488d26 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VERIGENE® II System |
Version Model Number | VERIGENE-II-6M-IVD |
Company DUNS | 965476641 |
Company Name | LUMINEX CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Serial Number | true |
Manufacturing Date | true |
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 |
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 |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840487101766 [Primary] |
NSU | Instrumentation for clinical multiplex test systems |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-12-25 |
Device Publish Date | 2019-12-17 |
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 | 2019-12-25The VERIGENE® II System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The VERIGENE II System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as automated amplification, array hybridization, and detection of target nucleic acid sequences. |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VERIGENE 78245832 2924979 Live/Registered |
LUMINEX CORPORATION 2003-05-05 |