Primary Device ID | 00840487100493 |
NIH Device Record Key | 66b16d92-51f7-4e00-802d-61faf5c5cd15 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | xTAG® Gastrointestinal Pathogen Panel (GPP) |
Version Model Number | I032C0316 |
Catalog Number | I032C0316 |
Company DUNS | 255371916 |
Company Name | Luminex Molecular Diagnostics, Inc |
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 | 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 |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com | |
Phone | +1(877)785-2323 |
support@luminexcorp.com |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840487100493 [Primary] |
PCH | Gastrointestinal pathogen panel multiplex nucleic acid-based 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 | 2019-11-26 |
Device Publish Date | 2016-09-09 |
00840487101872 - NxTAG® Respiratory Pathogen Panel v2 | 2024-06-28 The NxTAG® Respiratory Pathogen Panel v2 (NxTAG® RPP v2) is a multiplexed polymerase chain reaction (PCR) test intended for th |
00840487100417 - NxTAG® Respiratory Pathogen Panel | 2020-01-03 The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simul |
00840487100462 - xTAG® RVP (Respiratory Viral Panel) | 2020-01-03 The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection an |
00840487100486 - xTAG® RVP FAST (Respiratory Viral Panel Fast) | 2020-01-03 The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous de |
00840487100493 - xTAG® Gastrointestinal Pathogen Panel (GPP) | 2019-11-26The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and identification of nucleic acids from multiple gastroenteritis causing viruses, parasites and bacteria (including toxin gene detection) in human stool samples that are fresh, frozen or in a holding medium, from individuals with signs and symptoms of infectious colitis or gastroenteritis. |
00840487100493 - xTAG® Gastrointestinal Pathogen Panel (GPP) | 2019-11-26 The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and ide |
00840487100141 - xTAG® Cystic Fibrosis (CFTR) 39 kit v2 | 2019-10-28 The xTAG® Cystic Fibrosis 39 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in |
00840487100134 - xTAG® CYP2D6 Kit v3 | 2018-07-06 The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the |
00840487100172 - xTAG® CYP2C19 Kit v3 | 2018-07-06 The xTAG® CYP2C19 Kit v3 is an in vitro diagnostic test used to simultaneously detect and identify a panel of nucleotide varian |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() XTAG 88416429 not registered Live/Pending |
Guangzhou Huaju Information Technology Co., Ltd. 2019-05-06 |
![]() XTAG 88023855 not registered Live/Pending |
Seeonic, Inc. 2018-07-02 |
![]() XTAG 86770178 5033131 Live/Registered |
Mobex, Inc. 2015-09-28 |
![]() XTAG 85187358 4025320 Dead/Cancelled |
Alternatives Technologie Pharma Inc. 2010-11-30 |
![]() XTAG 79095998 4017961 Dead/Cancelled |
XAVIER MUÃOZ BELLVEHÃ 2010-11-12 |