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FDA 510(k)

CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test

K-Number: K262432 · 2026-10-14

ApplicantCorDx, Inc.
Decision Date2026-10-14
Product CodeSCA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is CorDx, Inc.. It received FDA 510(k) clearance on 2026-10-14 under 510(k) number K262432. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test?

CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test is a medical device that received FDA 510(k) clearance on 2026-10-14. The listed applicant is CorDx, Inc.. The 510(k) number is K262432.

When did CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test receive FDA 510(k) clearance?

CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test received FDA 510(k) clearance on 2026-10-14, under 510(k) number K262432.

Who is the listed applicant for CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test?

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 Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test?

The FDA product code for CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test is SCA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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.

K253882CorDx Tyfast COVID-19 Ag Rapid Test RxK240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test

Related Devices (Code: SCA)

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.

K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestACON Laboratories, Inc.K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc.K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProIhealth Labs, Inc.K251538Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp.K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc.K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc.

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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