What is FDA product code QVF?

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

SCoV-2 Ag Detect™ Rapid Test · Simple Point-Of-Care Device to Directly Detect Sars-Cov-2 Viral Targets from Clinical Specimens in Near-Patient Settings → Immunology & Microbiology

Name: SCoV-2 Ag Detect™ Rapid Test
Brand: SCoV-2 Ag Detect™ Rapid Test

3manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (1), Guangdong (1), elsewhere (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QVF
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Guangzhou Wondfo Biotech Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	44
BD Rapid Diagnostics (Suzhou) Co., Ltd.	China (Jiangsu) Pilot Free Trade Zone Suzhou Area		Manufacturer	6

Record

Regulatory record for SCoV-2 Ag Detect™ Rapid Test
Listed by	Inbios International, Inc., United States
FDA product code	QVF
Device type	Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Device class	Class 2
Regulation	21 CFR 866.3982
Establishment	Complaint-file establishment, Manufacturer, Exporter
Record published	2024-09-13
Record revised	2026-03-18 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for SCoV-2 Ag Detect™ Rapid Test
Catalogue number	Size	Status
COVAF-20		In distribution
COVAF-50		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
McKesson	Mckesson Medical-Surgical Inc.	2
BD Veritor System for Rapid Detection of SARS-CoV-2	Becton, Dickinson AND Company	1
Sofia 2	Quidel Corp.	1
WELLlife™	Wondfo USA Co., Ltd.	1
Osom COVID-19 Test	Sekisui Diagnostics, LLC	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K233358	2024-08-23

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

SCoV-2 Ag Detect™ Rapid Test