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FDA 510(k)

CorDx Tyfast COVID-19 Ag Rapid Test Rx

K-Number: K253882 · 2026-06-01

ApplicantCorDx, Inc.
Decision Date2026-06-01
Product CodeQVF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CorDx Tyfast COVID-19 Ag Rapid Test Rx is the device name listed in this FDA 510(k) record. The listed applicant is CorDx, Inc.. It received FDA 510(k) clearance on 2026-06-01 under 510(k) number K253882. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CorDx Tyfast COVID-19 Ag Rapid Test Rx?

CorDx Tyfast COVID-19 Ag Rapid Test Rx is a medical device that received FDA 510(k) clearance on 2026-06-01. The listed applicant is CorDx, Inc.. The 510(k) number is K253882.

When did CorDx Tyfast COVID-19 Ag Rapid Test Rx receive FDA 510(k) clearance?

CorDx Tyfast COVID-19 Ag Rapid Test Rx received FDA 510(k) clearance on 2026-06-01, under 510(k) number K253882.

Who is the listed applicant for CorDx Tyfast COVID-19 Ag Rapid Test Rx?

The FDA 510(k) record lists CorDx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CorDx Tyfast COVID-19 Ag Rapid Test Rx?

The FDA product code for CorDx Tyfast COVID-19 Ag Rapid Test Rx is QVF.

Other records listing CorDx, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test

Related Devices (Code: QVF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251289WELLlife COVID-19 Antigen Test RxGuangzhou Wondfo Biotech Co., Ltd.K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and CompanyK250273BinaxNOW COVID-19 Ag CardAbbott Diagnostics Scarborough, Inc.K233358SCoV-2 Ag Detect Rapid TestInBios International, Inc.K232377Healgen Rapid COVID-19 Antigen TestHealgen Scientific,, LLCK231187Nano-Check™ COVID-19 Antigen TestNano-Ditech Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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