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Test, Urine Leukocyte

FDA product code LJX · Class 1 · Hematology

181
Registered devices
30
Adverse events
5
Recalls
7
510(k) clearances

Devices with this code

Clinistix UTI Test Strips — Siemens Healthcare Diagnostics Inc.Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.Multistix® 8 SG Reagent Strips — Siemens Healthcare Diagnostics Inc.Exploro Urinary Tract Infection (UTI) Test — Safecare Biotech (Hangzhou) Co., Ltd.Rapid Response — BTNX IncAccustrip URS Strips + Reader — JANT PHARMACAL CORPORATIONTECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSURiSCAN 10 SGL strip — YD Diagnostics CORP.Medline — MEDLINE INDUSTRIES, INC.TECO DIAGNOSTICS — TECO DIAGNOSTICSEasy@Home Urinary Tract Infection Test Strips (10 Pack) — EASY HEALTHCARE CORPORATIONRapid Response — BTNX IncMission Urinalysis Reagent Strips — Acon Laboratories, Inc.TopCare — REESE PHARMACEUTICAL COMPANYMission Urinalysis Reagent Strips — Acon Laboratories, Inc.CLINITEK Novus® 10 Urinalysis Cassette 450 — Siemens Healthcare Diagnostics Inc.Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCMission Urinalysis Reagent Strips — Acon Laboratories, Inc.CLINITEK Status® Connector — Siemens Healthcare Diagnostics Inc.TECO DIAGNOSTICS — TECO DIAGNOSTICSMoore Medical — MOORE MEDICAL LLCMission Urinalysis Reagent Strips — Acon Laboratories, Inc.

Recent recalls

DateFirmReason
2026-04-02DFI Co., Ltd.The devices were distributed without required FDA premarket clearance or approval.
2025-11-22Changchun 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;
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2017-12-04Beckman Coulter Inc.A subset of Lot 7212154 A of the iChem VELOCITY Urine Chemistry strips has an incorrect pad placed in the location of the leukocytes pad. This will result in
2010-03-24ARKRAY USA INC.This recall has been initiated due to a labeling issue with the Hypoguard DiaScreen 4-way pH 100 strips. The front and back panel of the bottle carton lists fiv

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.