FDA Device Intelligence
Home › Device types › LCX

Kit, Test, Pregnancy, Hcg, Over The Counter

FDA product code LCX · Class 2 · Clinical Chemistry

880
Registered devices
236
Adverse events
25
Recalls
226
510(k) clearances

Devices with this code

LEADER — Cardinal Health 110, Inc.DG Health — DOLGENCORP, LLCPreview — WONDFO USA CO., LTD.First Response™ Pregnancy Test & Confirm Pregnancy — CHURCH & DWIGHT CO., INC.Shopko — SPD SWISS PRECISION DIAGNOSTICS GMBHCVP Health — SPD SWISS PRECISION DIAGNOSTICS GMBHDiscount Drug Mart One Step Pregnancy Test — DISCOUNT DRUG MART, INC.CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKroger One Step Pregnancy Test — KROGER CO., THECLARISSE — DELTA BRANDS INC.Topcare — Topco Associates, LLCHarris Teeter — Harris Teeter, LLCWalgreens — WALGREEN CO.Rexall — DOLGENCORP, LLCCVS Health Early Result Pregnancy Test — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDClearblue — SPD SWISS PRECISION DIAGNOSTICS GMBHKroger — KROGER CO., THEWondfo Pregnancy Test — WONDFO USA CO., LTD.Clearblue — SPD SWISS PRECISION DIAGNOSTICS GMBHEasy@Home Pregnancy Test (100 HCG strips) — EASY HEALTHCARE CORPORATIONClearblue — SPD SWISS PRECISION DIAGNOSTICS GMBHWalgreens — WALGREEN CO.DG health — DOLGENCORP, LLCArvolife — Clinical Guard

Recent recalls

DateFirmReason
2025-12-26GOLD STAR DISTRIBUTION INCPotential exposure of rodents and rodent activity in the distribution center.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2023-10-04Family Dollar Stores, Llc.Products were stored outside of labeled temperature requirements.
2023-10-04Family Dollar Stores, Llc.Products were stored outside of labeled temperature requirements.
2023-10-04Family Dollar Stores, Llc.Products were stored outside of labeled temperature requirements.
2023-05-22Universal Meditech Inc.Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa
2023-05-22Universal Meditech Inc.Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa
2023-05-22Universal Meditech Inc.Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa
2023-05-22Universal Meditech Inc.Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa
2023-05-22Universal Meditech Inc.Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.