Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
The Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets from Clinical Specimens in Near-Patient Settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens, designed for simple use by healthcare professionals in near-patient settings outside centralized laboratories, without requiring sample manipulation, transport to a specialized area, or complex analyte measurements. It aids in the diagnosis of COVID-19 infections. Classified as FDA Class 2 under regulation 866.3982, it requires 510(k) clearance in the Microbiology specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QVF
- Device Class
- FDA class 2
- Regulation Number
- 866.3982
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
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 another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx | Jun 01, 2026 | Substantially Equivalent | CorDx, Inc. |
| K251289 | WELLlife COVID-19 Antigen Test Rx | Oct 22, 2025 | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. |
| K243872 | BD Veritor System for SARS-CoV-2 | Jun 16, 2025 | Substantially Equivalent | Becton, Dickinson and Company |
| K250273 | BinaxNOW COVID-19 Ag Card | Jun 13, 2025 | Substantially Equivalent | Abbott Diagnostics Scarborough, Inc. |
| K233358 | SCoV-2 Ag Detect Rapid Test | Aug 23, 2024 | Substantially Equivalent | InBios International, Inc. |
| K232377 | Healgen Rapid COVID-19 Antigen Test | Apr 19, 2024 | Substantially Equivalent | Healgen Scientific,, LLC |
| K231187 | Nano-Check COVID-19 Antigen Test | Jan 23, 2024 | Substantially Equivalent | Nano-Ditech Corporation |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | Dec 13, 2023 | Substantially Equivalent | Quidel Corporation |
| DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Mar 08, 2023 | Unknown | Quidel Corporation |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.