Home › Device types › LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
FDA product code LCX · Class 2 · Clinical Chemistry
848
Registered devices
236
Adverse events
25
Recalls
226
510(k) clearances
Devices with this code
Kroger One Step Pregnancy Test — KROGER CO., THEPreKnow — IDUN SOLUTIONS LLCVeriQuick — FOURSTAR GROUP INC.Good Neighbor Pharmacy — Amerisourcebergen Drug CorporationNatural Cycles — Naturalcycles Nordic ABClinical Guard — Clinical GuardPremier Value — PHARMACY VALUE ALLIANCE, LLCWalgreens — WALGREEN CO.Walgreens — WALGREEN CO.CVS Health Digital Pregnancy Test — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPremom Ovulation Tests (40 LH strips + 10 HCG strips ) — EASY HEALTHCARE CORPORATIONFirst Signal — SPD SWISS PRECISION DIAGNOSTICS GMBHWondfo Pregnancy Test — WONDFO USA CO., LTD.co-innovation — Co-Innovation Biotech Co., LtdPregnancy (hCG) Rapid Test Midstream — Hangzhou AllTest Biotech Co., Ltd.AMPLIM — AMPLIM, LLCPreview — WONDFO USA CO., LTD.First Response™ Pregnancy Rapid Result Pregnancy Test — CHURCH & DWIGHT CO., INC.Lia Pregnancy Test — Lia Diagnostics, Inc.Proov — Mfb Fertility, Inc.Easy@Home Pregnancy Test (20 HCG strips) — EASY HEALTHCARE CORPORATIONKroger — KROGER CO., THEAmazewell — Guangzhou Decheng Biotechnology Co., LTDWell at Walgreens — WALGREEN CO.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-26 | GOLD STAR DISTRIBUTION INC | Potential exposure of rodents and rodent activity in the distribution center. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2023-10-04 | Family Dollar Stores, Llc. | Products were stored outside of labeled temperature requirements. |
| 2023-10-04 | Family Dollar Stores, Llc. | Products were stored outside of labeled temperature requirements. |
| 2023-10-04 | Family Dollar Stores, Llc. | Products were stored outside of labeled temperature requirements. |
| 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 |
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