FDA.reportPublic FDA data

Flo

Primary DI
06970429840195
Brand
Flo
Company
Co-Innovation Biotech Co., Ltd
Model
1
Device description
Flo PREGNANCY TEST STRIP
Published
2026-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LCXKit, Test, Pregnancy, Hcg, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213808000Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test MidstreamCo-Innovation Biotech Co., Ltd.2022-04-05LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970429840192PackageGS15Not in Commercial Distribution
26970429840199PackageGS110Not in Commercial Distribution
36970429840196PackageGS125Not in Commercial Distribution
46970429840193PackageGS150Not in Commercial Distribution
06970429840195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697042984019216970429840192
2697042984019926970429840199
3697042984019636970429840196
4697042984019346970429840193
06970429840195069704298401956970429840195

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, 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 used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.

Regulatory Flags#

DUNS number
421302978
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
06970429840171co-innovationHCG TEST2023-04-28
06970429844124Flo12026-03-31
06970429844117co-innovationLH TEST2025-10-20
06970429843417co-innovationCOT TEST2025-05-19
16970429843414co-innovationCOT TEST2025-05-19
06970429843318co-innovationFYL TEST2024-08-20
16970429843315co-innovationFYL TEST2024-08-20
06970429841345DTPM13P2023-12-08
06970429841635DTPM16P2023-12-08
16970429841342DTPM13P2023-12-08
16970429841632DTPM16P2023-12-08
06970429840102Co-innovationHCG Strip/4.0mm2017-03-23
06970429840119MomMedHCG TEST STRIP 2018-12-31
06970429840126AICAREHCG Pregnancy Test2019-03-18
06970429840133HealthyWiserHCG Test Strip2016-10-31
06970429840157HCG TEST STRIPHCG3.52019-12-25
06970429840164PREGABLE12021-06-02
06970429840300Co-innovationHCG Cassette2017-03-23
16970429840154HCG TEST STRIPHCG3.52019-12-25
16970429840178co-innovationHCG TEST2023-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00049696240482VeriQuickFOURSTAR GROUP INC.LCX2026-04-13
00072036734280Harris TeeterHarris Teeter, LLCLCX2026-02-27
00072036734297Harris TeeterHarris Teeter, LLCLCX2026-02-27
00075450847635Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847666Hy-Vee® Analog Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847673Hy-Vee® Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00195515147545AmazonAMAZON.COM SERVICES LLCLCX2026-02-20
00195515147552AmazonAMAZON.COM SERVICES LLCLCX2026-02-20
00311917083803WalgreensWALGREEN CO.LCX2026-02-17
00311917083957WalgreensWALGREEN CO.LCX2026-02-17
00311917084022WalgreensWALGREEN CO.LCX2026-02-17
00070552251137Winco Foods One Step Pregnancy TestWINCO FOODS, LLCLCX2026-02-09
00311917083452WalgreensWALGREEN CO.LCX2026-02-05
00311917083513WalgreensWALGREEN CO.LCX2026-02-05
00311917083575WalgreensWALGREEN CO.LCX2026-02-05
00045611010000SURESIGN™ Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010017SURESIGN™ Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010024SURESIGN™ Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010031SURESIGN™ Early Detection Pregnancy Test + Digital Pregancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
00045611010048SURESIGN™ Ovulation & Pregnancy Rapid TestsGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28
10810174471059HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
10810174471073HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
10810174471097HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
10810174471110HORMONElife™WONDFO USA CO., LTD.LCX2025-12-05
00197870203805H.E.BH. E. BUTT GROCERY COMPANYLCX2025-11-28
00197870203812H.E.BH. E. BUTT GROCERY COMPANYLCX2025-11-28
00197870203843H.E.BH. E. BUTT GROCERY COMPANYLCX2025-11-12
00197870203836H.E.BH. E. BUTT GROCERY COMPANYLCX2025-11-11
00311917077550WalgreensWALGREEN CO.LCX2025-10-10
00311917077567WalgreensWALGREEN CO.LCX2025-10-10