# Applied BioCode, Inc. (manufacturer, Santa Fe Springs, CA): 12 new FDA device listings, incl. instrumentation for clinical multiplex test systems

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | Applied BioCode, Inc. |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | Santa Fe Springs, CA, US |
| New listings | 12 |
| Devices | Instrumentation For Clinical Multiplex Test Systems; Respiratory Virus Panel Nucleic Acid Assay System; Non-Sars Coronavirus Multiplex Nucleic Acid Assay; Parainfluenza Multiplex Nucleic Acid Assay; Mycoplasma Pneumoniae Dna Assay System; Influenza A Virus Subtype Differentiation Nucleic Acid Assay; Human Metapneumovirus (Hmpv) Rna Assay System; Chlamydophila Pneumoniae Dna Assay System; Influenza A And Influenza B Multiplex Nucleic Acid Assay; Bordetella Pertussis Dna Assay System |
| Product codes | NSU, OCC, OTG, OOU, OZX, OEP, OEM, OZY, OZE, OZZ, PCH, OOI |
| Device classes | Class II |
| Medical specialties | Clinical Chemistry, Microbiology |
| Brand names | BioCode Respiratory Pathogen Panel (RPP); BioCode Gastrointestinal Pathogen Panel (GPP) |
| First new listing | 2026-09-30 |
| Latest new listing | 2026-09-30 |
| FDA registration number | 3007799234 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.