Healgen Rapid COVID-19 Antigen Test
FDA 510(k) K232377 · Healgen Scientific,, LLC
Submission
- Device name
- Healgen Rapid COVID-19 Antigen Test
- Applicant
- Healgen Scientific,, LLC
Houston, TX, US - Received
- August 8, 2023
- Decision date
- April 19, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QVF – Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3982
- Specialty
- Microbiology
A simple point-of-care device to detect SARS-CoV-2 viral targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to…
Other 510(k)s with product code QVF
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|---|---|---|---|
| K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAQVF · Dual Track | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 09/04/2026SE |
| K253882 | CorDx Tyfast COVID-19 Ag Rapid Test RxQVF · Dual Track | CorDx, Inc. | 06/01/2026SE |
| K251289 | WELLlife COVID-19 Antigen Test RxQVF · Dual Track | Guangzhou Wondfo Biotech Co., Ltd. | 10/22/2025SE |
| K243872 | BD Veritor System for SARS-CoV-2QVF · Dual Track | Becton, Dickinson and Company | 06/16/2025SE |
| K250273 | BinaxNOW COVID-19 Ag CardQVF · Dual Track | Abbott Diagnostics Scarborough, Inc. | 06/13/2025SE |
| K233358 | SCoV-2 Ag Detect Rapid TestQVF · Dual Track | InBios International, Inc. | 08/23/2024SE |
| K231187 | Nano-Check COVID-19 Antigen TestQVF · Traditional | Nano-Ditech Corporation | 01/23/2024SE |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetQVF · Special | Quidel Corporation | 12/13/2023SE |
More from Quidel Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-TestQYT · Traditional | 04/13/2026SE |
| K253705 | Healgen® Accurate Oral Fluid Drug TestDJC · Traditional | 03/16/2026SE |
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestNFW · Traditional | 02/12/2026SE |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | 12/23/2025SE |
| K251800 | Healgen® URS Test StripsJMT · Traditional | 12/23/2025SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | 08/15/2025SE |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…NGL · Traditional | 12/17/2024SE |
| K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl…NGL · Traditional | 05/13/2024SE |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | 04/12/2024SE |
| K231045 | Healgen URS Test StripsLJX · Traditional | 06/16/2023SE |
Questions and answers
When was Healgen Rapid COVID-19 Antigen Test cleared by the FDA?
Healgen Rapid COVID-19 Antigen Test (K232377) received a 510(k) decision of Substantially Equivalent on April 19, 2024, 255 days after the submission was received.
What is the product code of K232377?
The FDA product code is QVF – Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings, a Class II (moderate risk) device regulated under 21 CFR 866.3982.