# Autonomous Medical Devices Incorporated (manufacturer, Santa Ana, CA): 5 new FDA device listings, incl. assayed external control material for microbiology nucleic acid amplif

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Autonomous Medical Devices Incorporated |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | Santa Ana, CA, US |
| New listings | 5 |
| Devices | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays; Respiratory Virus Panel Nucleic Acid Assay System; Real Time Nucleic Acid Amplification System; Influenza A And Influenza B Multiplex Nucleic Acid Assay; Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents |
| Product codes | PMN, OCC, OOI, OZE, QOF |
| Device classes | Class II |
| Medical specialties | Microbiology, Clinical Chemistry |
| Brand names | Fast PCR Instrument; Fast PCR Mini Respiratory Panel Positive External Control; Fast PCR Mini Respiratory Panel; Fast PCR Mini Respiratory Panel Negative External Control |
| First new listing | 2026-06-16 |
| Latest new listing | 2026-06-16 |
| FDA registration number | 3023999024 |
| 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.

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.