FDA device listing
BioCode Respiratory Pathogen Panel (RPP)
FDA device listing 1843441856 · Applied BioCode, Inc.
Key facts
| Proprietary names | BioCode Respiratory Pathogen Panel (RPP) |
|---|---|
| Owner/operator | Applied BioCode, Inc. |
| Owner/operator number | 10029149 |
| Premarket submissions | K254139 |
| Product codes | NSU, OCC, OEM, OEP, OOU, OTG, OZE, OZX, OZY, OZZ |
| 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, 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, OZZ - Bordetella Pertussis Dna Assay System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570, 866.3980 |
| Review panels | Clinical Chemistry, Microbiology |
| Registered establishments | Applied BioCode, Inc. |
| Establishment registrations | 3007799234 |
| FEI numbers | 3007799234 |
| Establishment operations | Complaint File Establishment, 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