What is FDA product code SCA?

A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.

Immunology & Microbiology › Serological ReagentsMulti-Analyte Respiratory Virus Antigen Detection Test

Nano-Check Influenza+COVID-19 Dual Test

Name: Nano-Check Influenza+COVID-19 Dual Test
Brand: Nano-Check Influenza+COVID-19 Dual Test

The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B…

Registry build 21.09.26

The Nano-Check™ Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions. Positive results do not rule out bacterial infection or co-infection with other viruses.

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Zhejiang (1), Guangdong (1), Tianjin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code SCA
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
Biohit Healthcare (Hefei) Co., Ltd.	Hefei	Anhui	Contract manufacturer	4
Andon Health Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	22

Record

Regulatory record for Nano-Check Influenza+COVID-19 Dual Test
Listed by	Nano-Ditech Corporation, United States
FDA product code	SCA
Device type	Multi-Analyte Respiratory Virus Antigen Detection Test
Device class	Class 2
Regulation	21 CFR 866.3987
Establishment	Repacker / relabeller, Manufacturer, Exporter
Record published	2026-01-16

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 Influenza+COVID-19 Dual Test
Catalogue number	Size	Per pack	Status
MD8154		25	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
WELLlife™	Wondfo USA Co., Ltd.	22
BinaxNOW COVID-19/Flu A&B Combo Self Test	Alere Scarborough, Inc.	12
iHealth	iHealth Labs, Inc.	7
QuickFinder™ COVID-19/Flu Antigen Self Test	Osang Healthcare Co., Ltd.	4
Rapid Response	Btnx Inc.	3
Healgen	Healgen Scientific Limited Liability Company	3
HealthConfirm	Confirm Biosciences LLC	3
CareSuperb COVID-19/FluA&B Antigen Combo HomeTest	Access Bio, Inc.	3
McKesson	Mckesson Medical-Surgical Inc.	3
CVS Health	Woonsocket Prescription Center, Incorporated	2
COVID/Flu A&B RespiraDXTM Rapid Self-Test	Inbios International, Inc.	2
GenaCheck® COVID-19/Flu A&B Rapid Self-Test	Genabio Diagnostics Inc	2

Showing 12 of 28. All products under Multi-Analyte Respiratory Virus Antigen Detection Test

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K243561	2025-06-17

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.