FDA.reportPublic FDA data

Flowflex COVID-19 Antigen Home Test

Primary DI
20682607660265
Brand
Flowflex COVID-19 Antigen Home Test
Company
Acon Laboratories, Inc.
Model
L031-118B5, L031-125M5, L031-125N5, L031-125P5
Catalog number
L031-118B5, L031-125M5, L031-125N5, L031-125P5
Device description
1 Test per kit (L031-118B5):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L031-125M5): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L031-125N5): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L031-125P5): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
Published
2026-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYTOver-the-Counter COVID-19 Antigen Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYTOver-The-Counter Covid-19 Antigen TestMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00682607660261PackageGS11In Commercial Distribution
00682607660278PackageGS12In Commercial Distribution
00682607660285PackageGS15In Commercial Distribution
00682607660476PackageGS125In Commercial Distribution
10682607533302PackageGS16In Commercial Distribution
10682607533319PackageGS16In Commercial Distribution
10682607533326PackageGS16In Commercial Distribution
10682607660268PackageGS112In Commercial Distribution
10682607660275PackageGS112In Commercial Distribution
10682607660282PackageGS112In Commercial Distribution
20682607533262PackageGS1300In Commercial Distribution
20682607533279PackageGS18In Commercial Distribution
20682607533286PackageGS118In Commercial Distribution
20682607533309PackageGS18In Commercial Distribution
20682607533316PackageGS18In Commercial Distribution
20682607533323PackageGS16In Commercial Distribution
20682607533330PackageGS148In Commercial Distribution
20682607533347PackageGS148In Commercial Distribution
20682607533354PackageGS136In Commercial Distribution
20682607660265PackageGS124In Commercial Distribution
20682607660272PackageGS1210In Commercial Distribution
20682607660289PackageGS1120In Commercial Distribution
20682607660470PackageGS124In Commercial Distribution
00682607002306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00682607660261006826076602616826076602610682607660261
00682607660278006826076602786826076602780682607660278
00682607660285006826076602856826076602850682607660285
00682607660476006826076604766826076604760682607660476
1068260753330210682607533302
1068260753331910682607533319
1068260753332610682607533326
1068260766026810682607660268
1068260766027510682607660275
1068260766028210682607660282
2068260753326220682607533262
2068260753327920682607533279
2068260753328620682607533286
2068260753330920682607533309
2068260753331620682607533316
2068260753332320682607533323
2068260753333020682607533330
2068260753334720682607533347
2068260753335420682607533354
2068260766026520682607660265
2068260766027220682607660272
2068260766028920682607660289
2068260766047020682607660470
00682607002306006826070023066826070023060682607002306

GMDN Terms#

Term, Definition table
TermDefinition
SARS-CoV-2 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 severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
781100966
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00682607002306Flowflex COVID-19 Antigen Home TestAcon Laboratories, Inc.QYT2026-01-26
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00810143620382GenaCheck® COVID-19 Rapid Self-Test 20TGenabio Diagnostics Inc.QYT2026-01-21
00810143620399GenaCheck® COVID-19 Rapid Self-Test 4TGenabio Diagnostics Inc.QYT2026-01-21
B379C19S21COVID-19 Detect™ Rapid Self -TestINBIOS INTERNATIONAL, INCQYT2026-01-16
00850010224275CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
00850010224305CareSuperb COVID-19 Antigen Home TestAccess Bio Inc.QYT2026-01-05
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