Who else makes this device?

Name: Ramp® RSV Test KIT; 25 Tests
Brand: Ramp® RSV Test KIT; 25 Tests

Immunology & Microbiology › Serological ReagentsAntigen, 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…

Registry build 21.09.26

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 aspirate), and nasopharyngeal swab (NP swab) samples

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 Ramp® RSV Test KIT; 25 Tests
Listed by	Response Biomedical Corp., Canada
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
510(k)	K091235
Record published	2017-08-31
Record revised	2025-11-14 (version 4)

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
Storage	Special storage condition: Store unopened at 15 to 30°C (59 to 86°F). Do not freeze.

Catalogue Numbers

Catalogue numbers for Ramp® RSV Test KIT; 25 Tests
Catalogue number	Size	Status
C1108	One test kit with 25 pouches, each containing 1 RAMP® test cartridge and 1 test tip, and 25 RAMP® buffer vials	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
Nano-Check RSV Test	Nano-Ditech Corporation	1
Osom RSV Test	Sekisui Diagnostics, LLC	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
K091235	2009-07-24

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.