Home › Device types › NGE
Test, Luteinizing Hormone (Lh), Over The Counter
FDA product code NGE · Class 1 · Clinical Chemistry
196
Registered devices
6
Adverse events
10
Recalls
6
510(k) clearances
Devices with this code
Clinical Guard — Clinical GuardMissLan — Guangzhou Decheng Biotechnology Co., LTDFERTICARE — Weihai Kangzhou Biotechnology Engineering Co., LtdClearblue — SPD SWISS PRECISION DIAGNOSTICS GMBHFERTICARE — Weihai Kangzhou Biotechnology Engineering Co., Ltdkozekoze — Guangzhou Decheng Biotechnology Co., LTDDAVID Ovulation Test — Equinox Biotech Co., Ltd.One Step® LH Ovulation Rapid Test Dipstick (Urine) — Guangzhou Decheng Biotechnology Co., LTDZacurate — EINSTEIN ASSOCIATES LLCPreview — WONDFO USA CO., LTD.FERTICARE — Weihai Kangzhou Biotechnology Engineering Co., LtdHORMONElife™ — WONDFO USA CO., LTD.Amazewell — Guangzhou Decheng Biotechnology Co., LTDGenaCheck®LH At-Home Ovulation Prediction Test — Genabio Diagnostics Inc.Surearly™ Digital Ovulation Test — Sugentech Inc._Osong BranchPregmate Ovulation Test Strips (50 Count) — Pregmate LLCClearblue — SPD SWISS PRECISION DIAGNOSTICS GMBHFERTICARE — Weihai Kangzhou Biotechnology Engineering Co., LtdAMPLIM Ovulation Test Kit — AMPLIM, LLCLittleBegin — Hangzhou Laihe Biotech Co.,Ltd.Natural Cycles — Naturalcycles Nordic ABLittleBegin — Hangzhou Laihe Biotech Co.,Ltd.Clearblue — SPD SWISS PRECISION DIAGNOSTICS GMBHCorDx Tyfast — CORETESTS, INC.
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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