NxTAG® Respiratory Pathogen Panel I051C0447
GUDID 00840487100417
The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection.
Luminex Molecular Diagnostics, Inc
Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 00840487100417 |
| NIH Device Record Key | e65fc748-d21c-417c-add1-cf151a137f42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NxTAG® Respiratory Pathogen Panel |
| Version Model Number | I051C0447 |
| Catalog Number | I051C0447 |
| 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 |
Customer Support Contacts
| 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 | |
| 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 | |
| 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 |
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 |
| 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 |
| 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 | 00840487100417 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152386
FDA Product Code
| OTG | Non-sars coronavirus multiplex nucleic acid assay |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-03 |
| Device Publish Date | 2016-09-09 |
Devices Manufactured by Luminex Molecular Diagnostics, Inc
| 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 | 2020-01-03The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. |
| 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) | 2019-11-26 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 |
Trademark Results [NxTAG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NXTAG 86290434 4757427 Live/Registered |
Luminex Corporation 2014-05-23 |
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