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) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple 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) 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: 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
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: support@luminexcorp.com
• Phone: +1(877)785-2323
• Email: 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

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

• 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
• 00840487100455 - xTAG® Cystic Fibrosis Mutation Detection Kit: 2018-07-06 The xTAG® Cystic Fibrosis Kit is a device used to simultaneously detect and identify a panel of mutations and variants in the c