CorDx Tyfast COVID-19 Ag Rapid Test Rx— 510(k) K253882

Name: FDA 510(k) clearance K253882
Creator: U.S. Food and Drug Administration
Published: 2026-06-01

Substantially Equivalent

CorDx, Inc.

FDA 510(k) clearance K253882 for CorDx Tyfast COVID-19 Ag Rapid Test Rx, Substantially Equivalent on 2026-06-01. Applicant: CorDx, Inc.. Device class: 2.

Clearance details

Applicant: CorDx, Inc.
Product code: Code QVF
Device class: Class 2
Regulation: 21 CFR 866.3982
Advisory panel: Microbiology
Date received: 2025-12-04
Decision date: 2026-06-01
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QVF

view all

K254264 — Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA2026-09-04
K251289 — WELLlife COVID-19 Antigen Test Rx2025-10-22
K243872 — BD Veritor System for SARS-CoV-22025-06-16
K250273 — BinaxNOW COVID-19 Ag Card2025-06-13
K233358 — SCoV-2 Ag Detect Rapid Test2024-08-23

More clearances from CorDx, Inc.

view all

K240728 — CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test2024-06-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.