# CorDx, Inc. (manufacturer, Alpharetta, GA): 2 new FDA device listings, incl. multi-analyte respiratory virus antigen detection test

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | CorDx, Inc. |
| Owner / operator | CorDx |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Alpharetta, GA, US |
| New listings | 2 |
| Devices | Multi-Analyte Respiratory Virus Antigen Detection Test; Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings |
| Product codes | SCA, QVF |
| Device classes | Class II |
| Medical specialties | Microbiology |
| Brand names | CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test; CorDx Tyfast COVID-19 Ag Rapid Test Rx |
| First new listing | 2026-08-14 |
| Latest new listing | 2026-10-19 |
| FDA registration number | 3031823359 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- 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: 2026-11-04T21:52:36.524Z.
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.