FDA device listing
ePlex® Respiratory Pathogen (RP) Panel
FDA device listing 1887031681 · Hochuen Medical Technology Co.,Ltd.
Key facts
| Proprietary names | ePlex® Respiratory Pathogen (RP) Panel |
|---|---|
| Owner/operator | Hochuen Medical Technology Co.,Ltd. |
| Owner/operator number | 10055509 |
| Product codes | NSU, OCC, OEM, OEP, OOU, OQW, OTG, OZE, OZX, OZY |
| Device names | NSU - Instrumentation For Clinical Multiplex Test Systems, OCC - Respiratory Virus Panel Nucleic Acid Assay System, OEM - Human Metapneumovirus (Hmpv) Rna Assay System, OEP - Influenza A Virus Subtype Differentiation Nucleic Acid Assay, OOU - Parainfluenza Multiplex Nucleic Acid Assay, OQW - 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification, OTG - Non-Sars Coronavirus Multiplex Nucleic Acid Assay, OZE - Influenza A And Influenza B 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 | Hochuen Medical Technology Co.,Ltd. |
| Establishment registrations | 3013019728 |
| FEI numbers | 3013019728 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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