Primary Device ID | 00840487101452 |
NIH Device Record Key | 7098f863-67e0-47cf-ac4f-7110f6e84bfc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ARIES® Bordetella Assay |
Version Model Number | 50-10037 |
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 | true |
Device Combination Product | false |
Single Use | true |
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 |
Phone | +1(512)381-4397 |
support@luminexcorp.com |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840487101452 [Primary] |
OZZ | Bordetella pertussis dna assay system |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-05-09 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ARIES 98381077 not registered Live/Pending |
Apex Technology, Inc. 2024-01-29 |
ARIES 98276383 not registered Live/Pending |
Northwestern Memorial HealthCare 2023-11-17 |
ARIES 97474716 not registered Live/Pending |
Vy Corporation 2022-06-24 |
ARIES 97365584 not registered Live/Pending |
Aries Tickets, Inc. 2022-04-15 |
ARIES 97294135 not registered Live/Pending |
TALNUA, LLC 2022-03-03 |
ARIES 97017331 not registered Live/Pending |
MiRus, LLC 2021-09-08 |
ARIES 90978886 not registered Live/Pending |
Aries USA, Inc. 2020-10-19 |
ARIES 90851491 not registered Live/Pending |
Our Next Energy Inc. 2021-07-27 |
ARIES 90696904 not registered Live/Pending |
Delta Enterprise Corp. 2021-05-07 |
ARIES 90373154 not registered Live/Pending |
Nordco Inc. 2020-12-10 |
ARIES 90263282 not registered Live/Pending |
Aries USA, Inc. 2020-10-19 |
ARIES 90067298 not registered Live/Pending |
Homesick BVG LLC 2020-07-22 |