SCoV-2 Ag Detect Rapid Test

Q: What is the product code of K233358?

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.

FDA 510(k) K233358 · InBios International, Inc.

Substantially Equivalent

510(k) numberK233358

Submission

Device name: SCoV-2 Ag Detect Rapid Test
Applicant: InBios International, Inc.
Seattle, WA, US
Received: September 29, 2023
Decision date: August 23, 2024
Decision: Substantially Equivalent (SESE)
Type: Dual Track 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

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

510(k)	Device	Applicant	Decision
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
K232377	Healgen Rapid COVID-19 Antigen TestQVF · Traditional	Healgen Scientific,, LLC	04/19/2024SE
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
K251595	COVID-19 Detect Rapid Self -TestQYT · Traditional	10/12/2025SE
K181473	DENV Detect NS1 ELISAQCU · Traditional	08/27/2018SE
K161947	Chagas Detect Plus Rapid TestMIU · Traditional	12/16/2016SE
K141341	CL Detect Rapid TestPIT · Traditional	11/14/2014SE

Questions and answers

When was SCoV-2 Ag Detect Rapid Test cleared by the FDA?

SCoV-2 Ag Detect Rapid Test (K233358) received a 510(k) decision of Substantially Equivalent on August 23, 2024, 329 days after the submission was received.

What is the product code of K233358?

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.