FDA device listing
NXTAG Respiratory Pathogen Panel
FDA device listing 1947463712 · Luminex Corporation
Key facts
| Proprietary names | NXTAG Respiratory Pathogen Panel |
|---|---|
| Owner/operator | Luminex Corporation |
| Owner/operator number | 9032042 |
| Premarket submissions | K242613 |
| Product codes | NXD, OCC, OEM, OEP, OOI, OOU, OTG, OZX, OZY |
| Device names | NXD - Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna, OCC - Respiratory Virus Panel Nucleic Acid Assay System, OEM - Human Metapneumovirus (Hmpv) Rna Assay System, OEP - Influenza A Virus Subtype Differentiation Nucleic Acid Assay, OOI - Real Time Nucleic Acid Amplification System, OOU - Parainfluenza Multiplex Nucleic Acid Assay, OTG - Non-Sars Coronavirus Multiplex Nucleic Acid Assay, OZX - Mycoplasma Pneumoniae Dna Assay System, OZY - Chlamydophila Pneumoniae Dna Assay System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570, 866.3332, 866.3980 |
| Review panels | Clinical Chemistry, Microbiology |
| Registered establishments | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| Establishment registrations | 3002777243 |
| FEI numbers | 3002777243 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database