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FDA 510(k)

Healgen Rapid COVID-19 Antigen Test

K-Number: K232377 · 2024-04-19

ApplicantHealgen Scientific,, LLC
Decision Date2024-04-19
Product CodeQVF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Healgen Rapid COVID-19 Antigen Test is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K232377. 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 Healgen Rapid COVID-19 Antigen Test?

Healgen Rapid COVID-19 Antigen Test is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K232377.

When did Healgen Rapid COVID-19 Antigen Test receive FDA 510(k) clearance?

Healgen Rapid COVID-19 Antigen Test received FDA 510(k) clearance on 2024-04-19, under 510(k) number K232377.

Who is the listed applicant for Healgen Rapid COVID-19 Antigen Test?

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

What is the FDA product code for Healgen Rapid COVID-19 Antigen Test?

The FDA product code for Healgen Rapid COVID-19 Antigen Test is QVF.

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.

NCT05765396SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies (Level42)COMPLETED

Other records listing Healgen Scientific,, LLC 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.

K260095Heal-Check Rapid COVID-19 Antigen Self-TestK253705Healgen® Accurate Oral Fluid Drug TestK252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestK253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardK251800Healgen® URS Test StripsK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)

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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.

K253882CorDx Tyfast COVID-19 Ag Rapid Test RxCorDx, Inc.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.K231187Nano-Check™ COVID-19 Antigen TestNano-Ditech Corporation

Official Source

View on FDA Database →

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

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