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

BinaxNOW COVID-19/Flu A&B

Name: BinaxNOW COVID-19/Flu A&B
Brand: BinaxNOW COVID-19/Flu A&B

Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

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 BinaxNOW COVID-19/Flu A&B
Listed by	Alere Scarborough, Inc., United States
FDA product code	SCA
Device type	Multi-Analyte Respiratory Virus Antigen Detection Test
Device class	Class 2
Regulation	21 CFR 866.3987
Record published	2025-01-30

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

Catalogue Numbers

Catalogue numbers for BinaxNOW COVID-19/Flu A&B
Catalogue number	Size	Status
20002054		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

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.