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Test, Urine Leukocyte
FDA product code LJX · Class 1 · Hematology
195
Registered devices
30
Adverse events
5
Recalls
7
510(k) clearances
Devices with this code
Accutest — JANT PHARMACAL CORPORATIONRapid Response — BTNX IncTECO DIAGNOSTICS — TECO DIAGNOSTICSMoore Medical — MOORE MEDICAL LLCYodoc 10 — DFI CO.,LTDUrine Reagent Strips, 10-parameter — LW SCIENTIFIC, INC.URINE REAGENT STRIPS — Urit Medical Electronic Co., Ltd.Urine Reagent Strips — Urit Medical Electronic Co., Ltd.Metric — Jilin Test BIO-Electron Co.,LtdAUTION™ MAX AX-4022 Analyzer — ARKRAY USA, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Urine Chemistry Strips — Urit Medical Electronic Co., Ltd.Alltest Urinary Tract Infection Test — Hangzhou AllTest Biotech Co., Ltd.Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.TECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSMultistix® 10 SG Reagent Strips — Siemens Healthcare Diagnostics Inc.Detector UA 5 — Immunostics Company, IncTECO DIAGNOSTICS — TECO DIAGNOSTICSMission Urinalysis Reagent Strips — Acon Laboratories, Inc.AUTION™ Sticks 10EA Test Strips — ARKRAY USA, INC.Urine Reagent Strips — Urit Medical Electronic Co., Ltd.Serim® PeriScreen™ Test Strips — SERIM RESEARCH CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-02 | DFI Co., Ltd. | The devices were distributed without required FDA premarket clearance or approval. |
| 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. |
| 2017-12-04 | Beckman 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 |
| 2010-03-24 | ARKRAY 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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