NxTAG® Respiratory Pathogen Panel v2 I055C0465
GUDID 00840487101872
The NxTAG® Respiratory Pathogen Panel v2 (NxTAG® RPP v2) is a multiplexed polymerase chain reaction (PCR) test intended for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19.
Luminex Molecular Diagnostics, Inc
Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 00840487101872 |
| NIH Device Record Key | aa5b113f-025e-432d-a69e-4d1ed1743b3b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NxTAG® Respiratory Pathogen Panel v2 |
| Version Model Number | I055C0465 |
| Catalog Number | I055C0465 |
| 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 | true |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840487101872 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K231758
FDA Product Code
| QOF | Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-28 |
| Device Publish Date | 2024-06-20 |
Devices Manufactured by Luminex Molecular Diagnostics, Inc
| 00840487101872 - NxTAG® Respiratory Pathogen Panel v2 | 2024-06-28The NxTAG® Respiratory Pathogen Panel v2 (NxTAG® RPP v2) is a multiplexed polymerase chain reaction (PCR) test intended for the simultaneous, qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swab specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19. |
| 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) | 2019-11-26 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.