Home › Device types › NGE
Test, Luteinizing Hormone (Lh), Over The Counter
FDA product code NGE · Class 1 · Clinical Chemistry
174
Registered devices
6
Adverse events
10
Recalls
6
510(k) clearances
Devices with this code
Pregmate Ovulation Test Strips (25 Count) — Pregmate LLCNatural Cycles — Naturalcycles Nordic ABClinical Guard — Clinical GuardAmazewell — Guangzhou Decheng Biotechnology Co., LTDPremom Ovulation Tests (40 LH strips + 10 HCG strips ) — EASY HEALTHCARE CORPORATIONZacurate — EINSTEIN ASSOCIATES LLCWondfo — WONDFO USA CO., LTD.Proov — Mfb Fertility, Inc.RITE AID — NANTONG EGENS BIOLOGY TECHNIC CO., LTD.ovul — Ovulio Corp.One Step LH Ovulation Rapid Test Dipstick — Hangzhou AllTest Biotech Co., Ltd.Macro & Micro-Test LH Test — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.Wondfo — WONDFO USA CO., LTD.VeriQuick — FOURSTAR GROUP INC.MissLan — Guangzhou Decheng Biotechnology Co., LTDDAVID Ovulation Test Strip — Equinox Biotech Co., Ltd.Macro & Micro-Test LH Test — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.SURESIGN™ Digital Ovulation Rapid Test — Guangzhou Decheng Biotechnology Co., LTDPREGMATE — Guangzhou Decheng Biotechnology Co., LTDWondfo — WONDFO USA CO., LTD.One Step® LH Ovulation Rapid Test Dipstick (Urine) — Guangzhou Decheng Biotechnology Co., LTDFIRSTVIEW Luteinizing Hormone Rapid Test Strip — Safecare Biotech (Hangzhou) Co., Ltd.iProvèn — Masena Invest B.V.HORMONElife™ — WONDFO USA CO., LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2008-11-07 | Quest Products Inc. | The ovulation test strips were shipped without 510(k) premarket notification clearance from the FDA. |
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