Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are based in Zhejiang and Guangdong: 4 hold an FDA registration. 1 is a contract manufacturer.

BD Rapid Diagnostics (Suzhou) Co., Ltd.
Hangzhou Clongene Biotech Co., Ltd. Zhejiang
Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. Guangdong
Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer

How Is GQG Classified?

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus is FDA product code GQG, Class 1, 21 CFR 866.3480.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2003. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

BD Veritor™ System for Rapid Detection of RSV – Clia Waived Kit

Kit Rsv 30 Test Physician Veritor

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Clungene

The Clungene test is a lateral-flow immunoassay for qualitative detection of RSV nucleoprotein antigen in nasopharyngeal swab specimens. Its intended-use statement describes samples from…

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

QuickVue

QkVue RSV 10, 25T

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Easy Lab Pro RSV

Easy Lab Pro RSV - US

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

BinaxNOW Nasopharyngeal Swab Accessory Kit

Nasopharyngeal Swabs intended for use only with products manufactured by Abbott Diagnostics Scarborough, Inc.

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

BD Veritor™ System for Rapid Detection of RSV – Laboratory Kit

Kit Rsv 30 Test Hospital Veritor

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Imagen Respiratory Syncytial Virus (RSV)

Catalogue number K610211-2, listed by Oxoid, Ltd., United Kingdom, under Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus. 4 manufacturers in China are registered for this product code.

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

BinaxNOW RSV Control Swab Kit

Control Swabs intended for use only with BinaxNOW RSV products.

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Ramp® RSV Control Swabs

The RAMP® RSV control swabs are additional external control reagents to be used with RAMP® RSV test kits as part of a routine quality control program

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Ramp® RSV Test KIT; 25 Tests

The RAMP® RSV test is a qualitative immunochromatographic test that utilizes the RAMP® 200 instrument for the detection of RSV F-protein antigens in nasal wash, nasopharyngeal aspirate (NP…

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Osom RSV Test

OSOM RSV Test Old UDI Package Number 50742860100661

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Nano-Check RSV Test

The Nano-Check RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from…

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Rapid Response

Rapid Response RSV Test Cassette - A rapid test for the qualitative detection of Respiratory Syncytial Virus fusion protein from nasopharyngeal swab or nasal aspirate specimens. For in…

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

TRU RSV

TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash,…

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Red Tunica

The RedTunica™ RSV Antigen Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab…

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

FLU/RSV Positive Control

FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Sofia

Sofia RSV 25T, US

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Chorus Respiratory Syncytial Virus IgG

Catalogue number 81036, listed by Diesse Diagnostica Senese SPA, under Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus. 4 manufacturers in China are registered for this product code.

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

McKesson

RSV Antigen Test (12/kt, 48kt/cs)

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

BinaxNOW RSV

A rapid test for the qualitative detection of respiratory syncytial virus (RSV) in nasal wash and nasopharyngeal swab specimens.

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

RDS

RSV Test Kit US Version 135060

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer