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

Flowflex Plus COVID-19 + Flu A/B Home Test

Name: Flowflex Plus COVID-19 + Flu A/B Home Test
Brand: Flowflex Plus COVID-19 + Flu A/B Home Test

1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5…

Registry build 21.09.26

1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L03A-R0845): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L03A-R0945): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)

4manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

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 Flowflex Plus COVID-19 + Flu A/B Home Test
Listed by	Acon Laboratories, 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
Establishment	Contract manufacturer, Specification developer, Manufacturer
Record published	2026-01-30

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Special storage condition: The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on t
Packaging	Carton of 8, inner pack of 12, inner pack of 6, carton of 48, carton of 24, kit box of 5

Catalogue Numbers

Catalogue numbers for Flowflex Plus COVID-19 + Flu A/B Home Test
Catalogue number	Size	Status
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945		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
K261212	2026-07-10
K251749	2025-10-22
K250377	2025-05-10

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.