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| Product | Model | Company | Device type |
|---|---|---|---|
| AccuHome Pregnancy TestGermaine Laboratories, IncTotal human chorionic gonadotropin IVD, kit, rapid ICT, clinical | 89101 | Germaine Laboratories, Inc | Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical |
| Actim PROM ControlsActim OyInsulin-like growth factor binding protein 1 (IGFBP-1) IVD, control | 30800ETUS | Actim Oy | Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, control |
| AIMSTEP OVULATIONGermaine Laboratories, IncLuteinizing hormone (LH) IVD, kit, rapid ICT, clinical | 75030 | Germaine Laboratories, Inc | Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical |
| AmazewellGuangzhou Decheng Biotechnology Co., LTDMultiple female fertility marker IVD, kit, rapid ICT, clinical | APDG-5E | Guangzhou Decheng Biotechnology Co., LTD | Multiple female fertility marker IVD, kit, rapid ICT, clinical |
| CorDx TyfastCoretests, Inc.Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing | ACT21006-21 | Coretests, Inc. | Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing |
| DAVIDEquinox Biotech Co., Ltd.Natural conception assistance kit | 82283 | Equinox Biotech Co., Ltd. | Natural conception assistance kit |
| Detector hCG PersonalImmunostics Company, IncTotal human chorionic gonadotropin IVD, kit, rapid ICT, clinical | IDP-25 | Immunostics Company, Inc | Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical |
| Dollar GeneralDolgencorp, LLCTotal human chorionic gonadotropin IVD, kit, rapid ICT, clinical | One Step Pregnancy Test | Dolgencorp, LLC | Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical |
| Easy@Home Ovulation Test (50 LH strips+50 Cups)Easy Healthcare CorporationNatural conception assistance kit | EZW2-S | Easy Healthcare Corporation | Natural conception assistance kit |
| FloCo-Innovation Biotech Co., LtdLuteinizing hormone (LH) IVD, kit, rapid ICT, clinical | 1 | Co-Innovation Biotech Co., Ltd | Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical |
| FridaFridababy, LLCTotal human chorionic gonadotropin IVD, kit, rapid ICT, self-testing | 500001287 | Fridababy, LLC | Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing |
| Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) Detection Kit (ImmunochrJiangsu Macro & Micro-Test Med-Tech Co., Ltd.Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical | 20 tests/kit | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | Insulin-like growth factor binding protein 1 (IGFBP-1) IVD, kit, rapid ICT, clinical |
| iProvènMasena Invest B.V.Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical | FK-127-W-HCGtest | Masena Invest B.V. | Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical |
| kozekozeGuangzhou Decheng Biotechnology Co., LTDLuteinizing hormone (LH) IVD, kit, rapid ICT, self-testing | 10T | Guangzhou Decheng Biotechnology Co., LTD | Luteinizing hormone (LH) IVD, kit, rapid ICT, self-testing |
| One Step FSH Urine midstream TestHangzhou AllTest Biotech Co., Ltd.Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, clinical |
| One Step® Progesterone (PdG) Urine Test StripGuangzhou Decheng Biotechnology Co., LTDMultiple female fertility marker IVD, kit, rapid ICT, clinical | 6T | Guangzhou Decheng Biotechnology Co., LTD | Multiple female fertility marker IVD, kit, rapid ICT, clinical |
| OSOM Ultra hCG 25T KitSekisui Diagnostics, LLCHuman chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid | 1004 | Sekisui Diagnostics, LLC | Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid |
| SAS Serum/Urine hCGSA Scientific, Ltd.Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical | 087750 | SA Scientific, Ltd. | Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical |
| Surearly SMARTSugentech Inc._Osong BranchPhotometric/spectroscopic immunoassay analyser IVD | Surearly SMART (SSMD001E) | Sugentech Inc._Osong Branch | Photometric/spectroscopic immunoassay analyser IVD |
| Testahead Vaginal PH Rapid Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.Vaginal pH screening IVD, kit, rapid colorimetric, clinical | PH-6012 | Safecare Biotech (Hangzhou) Co., Ltd. | Vaginal pH screening IVD, kit, rapid colorimetric, clinical |