Who else makes this device?

Name: Nano-Check RSV Test
Brand: Nano-Check RSV Test

Immunology & Microbiology › Serological ReagentsAntigen, 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…

Registry build 21.09.26

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 patients with signs and symptoms of respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients aged 6 months to 6 years old, and adults over 60 years of age.

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (2), Guangdong (1), elsewhere (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GQG
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Hangzhou Clongene Biotech Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	21
Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Repacker / relabeller	21
BD Rapid Diagnostics (Suzhou) Co., Ltd.	China (Jiangsu) Pilot Free Trade Zone Suzhou Area		Manufacturer	6

Record

Regulatory record for Nano-Check RSV Test
Listed by	Nano-Ditech Corporation, United States
FDA product code	GQG
Device type	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Device class	Class 1
Regulation	21 CFR 866.3480
Establishment	Repacker / relabeller, Manufacturer, Exporter
Record published	2024-08-08

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, manufacturing date
Storage	Handling environment temperature 2 to 30 °C

Catalogue Numbers

Catalogue numbers for Nano-Check RSV Test
Catalogue number	Size	Per pack	Status
MD8152		20	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BinaxNOW RSV	Alere Scarborough, Inc.	4
RDS	American Bio Medica Corp.	2
McKesson	Mckesson Medical-Surgical Inc.	2
Sofia	Quidel Corp.	2
Rapid Response	Btnx Inc.	2
Chorus Respiratory Syncytial Virus IgG	Diesse Diagnostica Senese SPA	1
FLU/RSV Positive Control	Meridian Bioscience, Inc.	1
Red Tunica	Rodimedi & Associates Inc.	1
TRU RSV	Meridian Bioscience, Inc.	1
Osom RSV Test	Sekisui Diagnostics, LLC	1
Ramp® RSV Test KIT; 25 Tests	Response Biomedical Corp.	1
Ramp® RSV Control Swabs	Response Biomedical Corp.	1

Showing 12 of 20. All products under Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K240280	2024-07-30

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.