FDA.reportPublic FDA data

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

Primary DI
00810107290002
Brand
Flowflex Plus COVID-19 + Flu A/B Home Test
Company
Acon Laboratories, Inc.
Model
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
Catalog number
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
Device description
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)
Published
2026-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SCAMulti-analyte respiratory virus antigen detection test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCAMulti-Analyte Respiratory Virus Antigen Detection TestMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810107290019PackageGS11In Commercial Distribution
00810107290026PackageGS12In Commercial Distribution
00810107290033PackageGS15In Commercial Distribution
00810107290040PackageGS125In Commercial Distribution
10810107290016PackageGS112In Commercial Distribution
10810107290023PackageGS112In Commercial Distribution
10810107290030PackageGS112In Commercial Distribution
20810107290013PackageGS124In Commercial Distribution
20810107290020PackageGS118In Commercial Distribution
20810107290037PackageGS18In Commercial Distribution
30810107290010PackageGS1300In Commercial Distribution
30810107290027PackageGS1210In Commercial Distribution
30810107290034PackageGS1120In Commercial Distribution
30810107290041PackageGS124In Commercial Distribution
40810107290017PackageGS16In Commercial Distribution
40810107290024PackageGS16In Commercial Distribution
40810107290031PackageGS16In Commercial Distribution
50810107290014PackageGS18In Commercial Distribution
50810107290021PackageGS18In Commercial Distribution
50810107290038PackageGS16In Commercial Distribution
60810107290011PackageGS148In Commercial Distribution
60810107290028PackageGS148In Commercial Distribution
60810107290035PackageGS136In Commercial Distribution
70810107290032PackageGS110In Commercial Distribution
80810107290015PackageGS1252In Commercial Distribution
80810107290039PackageGS18In Commercial Distribution
00810107290002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810107290019008101072900198101072900190810107290019
00810107290026008101072900268101072900260810107290026
00810107290033008101072900338101072900330810107290033
00810107290040008101072900408101072900400810107290040
1081010729001610810107290016
1081010729002310810107290023
1081010729003010810107290030
2081010729001320810107290013
2081010729002020810107290020
2081010729003720810107290037
3081010729001030810107290010
3081010729002730810107290027
3081010729003430810107290034
3081010729004130810107290041
4081010729001740810107290017
4081010729002440810107290024
4081010729003140810107290031
5081010729001450810107290014
5081010729002150810107290021
5081010729003850810107290038
6081010729001160810107290011
6081010729002860810107290028
6081010729003560810107290035
7081010729003270810107290032
8081010729001580810107290015
8081010729003980810107290039
00810107290002008101072900028101072900020810107290002

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testingA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The kit can be stored at temperatures between 36-86°F (2-30°C).The test is stable until the expiration date printed on the sealed pouch. Do not freeze.

Contacts#

Phone, Email table
PhoneEmail
+1(800)838-9502support@aconlabs.com

Regulatory Flags#

DUNS number
781100966
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00682607541072On Call Lancets (33G)G124-10AG124-10A2026-03-30
00682607541065On Call Lancing DeviceG124-11AG124-11A2026-03-18
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TC131-2041C131-20412026-03-09
00682607690077Mission Cholesterol Optical Check DeviceC121-2021C121-20212026-03-09
00682607690084Mission Cholesterol Control SolutionC121-2011C121-20112026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TC131-2041C131-20412026-03-09
10682607690050Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TC131-2041C131-20412026-03-09
00682607690060Mission Cholesterol MeterC111-2021C111-20212026-03-09
10682607690074Mission Cholesterol Optical Check DeviceC121-2021C121-20212026-03-09
10682607690081Mission Cholesterol Control SolutionC121-2011C121-20112026-03-09
10682607690098Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TC131-2041C131-20412026-03-09
00682607541058On Call Lancets 30GG124-10AG124-10A2026-02-19
10682607541055On Call Lancets 30GG124-10AG124-10A2026-02-19
20682607200485Mission U120 Smart Urine AnalyzerU117-1012026-02-06
20682607200492Mission U120 Smart Urine AnalyzerU117-1112026-02-06
20682607200904Mission U120 Touch Urine AnalyzerU119-106-1012026-02-06
20682607200911Mission U120 Touch Urine AnalyzerU119-116-1012026-02-06
00682607541829On Call Stealth Lancing DeviceG124-18AG124-18A2026-02-03
20682607541823On Call Stealth Lancing DeviceG124-18AG124-18A2026-02-03
00810107290033Flowflex Plus COVID-19 + Flu A/B Home TestL03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945L03A-R0645, L03A-R0745, L03A-R0845, L03A-R09452026-01-30

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Primary DI, Brand, Company table
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B379RCFP251COVID/Flu A&B RespiraDXTM Rapid TestINBIOS INTERNATIONAL, INCSCA2025-10-06
B379RCFS21COVID/Flu A&B RespiraDXTM Rapid Self-TestINBIOS INTERNATIONAL, INCSCA2025-10-06