FDA.reportPublic FDA data

Flowflex Plus RSV + Flu A/B + COVID Home Test

Primary DI
00810107290224
Brand
Flowflex Plus RSV + Flu A/B + COVID Home Test
Company
Acon Laboratories, Inc.
Model
L03A-R1445, L03A-R1545, L03A-R1645, L03A-R1745
Catalog number
L03A-R1445, L03A-R1545, L03A-R1645, L03A-R1745
Device description
1 Test per kit (L03A-R1445):Test Cassette (1), Extraction Buffer Tube (1), Swab Guard (1), Nasal Swab (1); 2 Test per kit (L03A-R1545): Test Cassettes (2), Extraction Buffer Tubes (2), Swab Guards (2), Nasal Swabs (2); 5 Test per kit (L03A-R1645): Test Cassettes (5), Extraction Buffer Tubes (5), Swab Guards (5), Nasal Swabs (5); 25 Test per kit (L03A-R1745): Test Cassettes (25), Extraction Buffer Tubes (25), Swab Guards (25), Nasal Swabs (25)
Published
2025-11-06
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
00810107290231PackageGS11In Commercial Distribution
00810107290248PackageGS12In Commercial Distribution
00810107290255PackageGS15In Commercial Distribution
00810107290262PackageGS125In Commercial Distribution
10810107290238PackageGS112In Commercial Distribution
10810107290245PackageGS112In Commercial Distribution
10810107290252PackageGS112In Commercial Distribution
20810107290235PackageGS112In Commercial Distribution
20810107290242PackageGS112In Commercial Distribution
20810107290259PackageGS112In Commercial Distribution
30810107290232PackageGS148In Commercial Distribution
30810107290249PackageGS148In Commercial Distribution
30810107290256PackageGS136In Commercial Distribution
30810107290263PackageGS124In Commercial Distribution
40810107290246PackageGS118In Commercial Distribution
40810107290253PackageGS110In Commercial Distribution
00810107290224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810107290231008101072902318101072902310810107290231
00810107290248008101072902488101072902480810107290248
00810107290255008101072902558101072902550810107290255
00810107290262008101072902628101072902620810107290262
1081010729023810810107290238
1081010729024510810107290245
1081010729025210810107290252
2081010729023520810107290235
2081010729024220810107290242
2081010729025920810107290259
3081010729023230810107290232
3081010729024930810107290249
3081010729025630810107290256
3081010729026330810107290263
4081010729024640810107290246
4081010729025340810107290253
00810107290224008101072902248101072902240810107290224

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
00810107290002Flowflex 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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00811877012221BinaxNOW COVID-19/Flu A&B Combo Self TestAlere Scarborough, Inc.SCA2026-05-06
00311917077598WalgreensWALGREEN CO.SCA2026-04-28
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00840733101564statID Pro COVID-19/Flu A&BMERIDIAN BIOSCIENCE, INC.SCA2026-04-10
00810107290002Flowflex Plus COVID-19 + Flu A/B Home TestAcon Laboratories, Inc.SCA2026-01-30
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30014613340751QuickVue™ WONDFO USA CO., LTD.SCA2025-10-31
B379RCFP251COVID/Flu A&B RespiraDXTM Rapid TestINBIOS INTERNATIONAL, INCSCA2025-10-06
B379RCFS21COVID/Flu A&B RespiraDXTM Rapid Self-TestINBIOS INTERNATIONAL, INCSCA2025-10-06