# Cordx Labs, Inc. (other, Alpharetta, GA): 2 new FDA device listings, incl. simple point-of-care device to directly detect sars-cov-2 viral target

**Score:** 50/100

| Field | Value |
|---|---|
| Establishment | Cordx Labs, Inc. |
| Owner / operator | CorDx Labs, Inc. |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Alpharetta, GA, US |
| New listings | 2 |
| Devices | Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings; Pad, Heating, Powered |
| Product codes | QVF, IRT |
| Device classes | Class II |
| Medical specialties | Microbiology, Physical Medicine |
| Brand names | CorDx Tyfast COVID-19 Ag Rapid Test Rx; @AL21 Insect Bite Healer; Insect Bite Healer; CorDx @AL21 Insect Bite Healer |
| First new listing | 2026-07-13 |
| Latest new listing | 2026-08-12 |
| FDA registration number | 3034405508 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- 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: 2026-11-04T21:52:36.524Z.
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.