FDA.reportPublic FDA data

Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

Definition
A 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 intended to be used for self-testing by a layperson in the home or similar environment to detect pregnancy.
GUDID devices
43
Last updated
2026-08-03 17:33:42

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
86950996013099Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.GAHCG-101a2026-07-25
86950996019039Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.GAHCG-102a2026-07-25
86950996041122Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.GAHCG-103a2026-07-26
06950996006323Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.GAHCG-101a2026-07-23
06950996030694Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.GAHCG-103a2026-07-23
06950996067577Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.GAHCG-102a2026-07-23
00810174470543HORMONElife™WONDFO USA CO., LTD.DW1-S25-15BX-H2026-06-26
00816490021117HealgenHealgen Scientific Limited Liability CompanyGAHCG-102a2016-12-31
00816490021124HealgenHealgen Scientific Limited Liability CompanyGAHCG-101a2016-12-31
00816490021131HealgenHealgen Scientific Limited Liability CompanyGAHCG-103a2016-12-31
00816490021261HealgenHealgen Scientific Limited Liability CompanyGAHCG-105a2017-04-06
00816862026801WondfoWONDFO USA CO., LTD.DW1-M2025-07-03
00816862026986WondfoWONDFO USA CO., LTD.DW1-S10-25BX-CA2025-07-03
00816862027761HORMONElife™WONDFO USA CO., LTD.H1-M-25BX2025-11-28
00816862028270HORMONElife™WONDFO USA CO., LTD.H1-S-20BG2026-01-15
00850042559000ACCU NEWS Pregnancy Test MidstreamCORETESTS, INC.Midstream2022-08-31
00850042559765CorDx TyfastCORETESTS, INC.ACT21012-32025-03-07
00850042559826CorDx Tyfast CORETESTS, INC.ACT21006-72025-03-07
00850042559833CorDx Tyfast CORETESTS, INC.ACT21006-212025-03-07
00812203030889ChemtrueCHEMTRON BIOTECH INC721A01-CT2026-03-10
00816862028263HORMONElife™WONDFO USA CO., LTD.H1-S-20BG2026-01-15
00816862027747HORMONElife™WONDFO USA CO., LTD.H1-M-E10-1BX2025-12-01
00816862027754HORMONElife™WONDFO USA CO., LTD.H1-M-25BX2025-11-28
06974246462578T Testahead HCG Urine Test StripSafecare Biotech (Hangzhou) Co., Ltd.50 Tests2025-08-20
06974246462585T Testahead HCG Urine Test StripSafecare Biotech (Hangzhou) Co., Ltd.25 Tests2025-08-20
00194346473564EquateWAL-MART STORES, INC.6772964552025-07-24
00194346473571EquateWAL-MART STORES, INC.6772964532025-07-24
00194346473588EquateWAL-MART STORES, INC.6772964542025-07-24
00194346473601EquateWAL-MART STORES, INC.6771595742025-07-24
00194346473625EquateWAL-MART STORES, INC.6772964562025-07-24
06974246462547Welcheck HCG Urine Test MidstreamSafecare Biotech (Hangzhou) Co., Ltd.5 Tests2025-08-04
10816862026808WondfoWONDFO USA CO., LTD.DW1-M2025-07-03
10816862026983WondfoWONDFO USA CO., LTD.DW1-S10-25BX-CA2025-07-03
00850042559819CorDx TyfastCORETESTS, INC.ACT21006-32025-03-07
10850042559762CorDx TyfastCORETESTS, INC.ACT21012-32025-03-07
10850042559823CorDx Tyfast CORETESTS, INC.ACT21006-72025-03-07
10850042559830CorDx Tyfast CORETESTS, INC.ACT21006-212025-03-07
10810028774084FridaFridababy, LLC5000012872024-09-12
06974849369304Macro & Micro-Test HCG Pregnancy Test MidstreamJiangsu Macro & Micro-Test Med-Tech Co., Ltd.1 test/kit2023-11-27
06974849369311Macro & Micro-Test HCG Pregnancy Test MidstreamJiangsu Macro & Micro-Test Med-Tech Co., Ltd.20 tests/kit2023-11-27
06974849369328Macro & Micro-Test HCG Pregnancy Test MidstreamJiangsu Macro & Micro-Test Med-Tech Co., Ltd.3 tests/kit2023-11-27
06974849369335Macro & Micro-Test HCG Pregnancy Test MidstreamJiangsu Macro & Micro-Test Med-Tech Co., Ltd.5 tests/kit2023-11-27
06974246460833FIRSTVIEW hCG Urine Test StripSafecare Biotech (Hangzhou) Co., Ltd.HCG-10112023-09-05