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)

• 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
• 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

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
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• 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