Home GUDID 08809408863475
Surearly SMART Menopause Test
Primary DI 08809408863475
Brand Surearly SMART Menopause Test
Company Sugentech Inc._Osong Branch
Model Surearly SMART Menopause Test
Device description The Surearly SMART Menopause Test works by inserting the test stick into the Test reader, which measures color changes on the test stick. It detects FSH at a concentrationof 25 mIU/mL or greater. The test line utilizes a monoclonal FSH antibody and the test strip contains pre-dried antibodies with gold conjugates. When urine is absorbed, FSHcombines with antibody gold conjugates on the gold conjugate pad. The formed antigen-antibody complexes react with the anti-FSH antibody on the test line, resulting in red orpurple lines. The control line is displayed using goat anti-rabbit IgG antibody. Instead of confusing visual interpretation, the Surearly SMART Menopause Test provides easy-to-read and clear digital results both on the device and the App. The App also provides more information with hormone graphs and additional messages to help your comprehensive management of hormonal health.
Published 2025-05-15
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 Code Name NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08809408863475 Primary GS1 0 08809408863512 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08809408863475 08809408863475 8809408863475 08809408863512 08809408863512 8809408863512
GMDN Terms# Term, Definition table Term Definition Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of luteinizing hormone (LH) 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. It is not intended to be used for self-testing.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 30 Degrees Celsius Special Storage Condition, Specify 0 0 Keep away from direct sunlight, moisture and heat
Regulatory Flags# DUNS number 694860936 Device count 10 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08809408864113 Surearly SMART Surearly SMART SSFD001E 2026-05-08 08809408864199 Surearly SMART Ovulation Test Surearly SMART Ovulation Test SLHN020E 2026-05-08 08809408864304 Surearly SMART Ovulation Test Starter Kit Surearly SMART Ovulation Test Starter Kit LHKT001E 2026-05-08 08809408860214 Surearly™ Digital Ovulation Test SU-DR01-LH HLHM007E 2020-10-26 08809408860245 Surearly™ Digital Ovulation Test SU-DR01-LH HLHM020E 2020-10-26 08809408863499 Surearly SMART Surearly SMART (SSMD001E) 2025-05-15 08809408863505 PettyPip PettyPip CT10300E 2025-05-15 08809408860191 Surearly™ Digital Pregnancy Test SU-DR02-CG HCGR001E 2018-11-26 08809408860597 Surearly™ Pregnancy Test Strip HCGS003E 2018-11-26 08809408863482 Surearly SMART Ovulation Test Surearly SMART Ovulation Test 2025-05-15 08809408860870 Surearly™ Digital Ovulation Test SU-DR01-LH HLHM007E 2020-10-26 08809408860863 Surearly™ Digital Ovulation Test SU-DR01-LH HLHM020E 2020-10-26
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08809408864113 Surearly SMART Sugentech Inc._Osong Branch NGA 2026-05-08 06952062712664 Follicle-Stimulating Hormone (FSH) Menopause test ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD NGA 2026-03-20 06952062712688 Follicle-Stimulating Hormone (FSH) Menopause test ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD NGA 2026-03-20 00045611010055 SURESIGN™ Menopause (FSH) Rapid Test Guangzhou Decheng Biotechnology Co., LTD NGA 2026-01-28 50045611010050 SURESIGN™ Menopause (FSH) Rapid Test Guangzhou Decheng Biotechnology Co., LTD NGA 2026-01-28 20045611954018 EPT Menopause (FSH) Rapid Test Hangzhou AllTest Biotech Co., Ltd. NGA 2025-12-10 50045611954019 EPT Menopause (FSH) Rapid Test Hangzhou AllTest Biotech Co., Ltd. NGA 2025-12-10 06942598202326 One Step FSH Rapid Test Dipstick (Urine) Hangzhou AllTest Biotech Co., Ltd. NGA 2025-10-10 06942598202333 One Step FSH Rapid Test Dipstick (Urine) Hangzhou AllTest Biotech Co., Ltd. NGA 2025-10-10 06942598202340 One Step FSH Rapid Test Dipstick (Urine) Hangzhou AllTest Biotech Co., Ltd. NGA 2025-10-10 00810038638072 Easy@Home FSH Urine Test (5 Tests) EASY HEALTHCARE CORPORATION NGA 2025-10-06 06936983131025 One Step One Step FSH Urine test strip Hangzhou AllTest Biotech Co., Ltd. NGA 2025-08-29 06936983131018 One Step FSH Urine midstream Test Hangzhou AllTest Biotech Co., Ltd. NGA 2025-08-29 86936983131021 One Step One Step FSH Urine test strip Hangzhou AllTest Biotech Co., Ltd. NGA 2025-08-29 00850035206393 Proov Mfb Fertility, Inc. NGA 2025-08-15 00816862027242 HORMONElife™ WONDFO USA CO., LTD. NGA 2025-07-03 10816862027249 HORMONElife™ WONDFO USA CO., LTD. NGA 2025-07-03 08809408863499 Surearly SMART Sugentech Inc._Osong Branch NGA 2025-05-15 00810143620214 GenaCheck® FSH At-Home Menopause Test Genabio Diagnostics Inc. NGA 2025-02-26 00850059915370 GoldN Easy to Use FSH Test NOVODX Corporation NGA 2025-01-24 00816862026078 Wondfo WONDFO USA CO., LTD. NGA 2024-12-24 10816862026075 Wondfo WONDFO USA CO., LTD. NGA 2024-12-24 00860011489153 Vivoo VIVOSENS INC. NGA 2024-11-25 10860011489150 Vivoo VIVOSENS INC. NGA 2024-11-25 00816862024418 BABYLife WONDFO USA CO., LTD. NGA 2024-05-22 10816862024415 BABYLife WONDFO USA CO., LTD. NGA 2024-05-22 00633472602245 Clearblue SPD SWISS PRECISION DIAGNOSTICS GMBH NGA 2023-07-31 10633472602242 Clearblue SPD SWISS PRECISION DIAGNOSTICS GMBH NGA 2023-07-31 00810038634692 One Step FSH Urine Test Strip(10 Tests) EASY HEALTHCARE CORPORATION NGA 2023-07-19 10810038634699 One Step FSH Urine Test Strip(10 Tests) EASY HEALTHCARE CORPORATION NGA 2023-07-19