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Dye-Indicator, Ph (Urinary, Non-Quantitative)

FDA product code CEN · Class 1 · Clinical Chemistry

231
Registered devices
4
Adverse events
5
Recalls
11
510(k) clearances

Devices with this code

Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System — TECO DIAGNOSTICSAlltest Multi-Drug Rapid Urine Test Panel — Hangzhou AllTest Biotech Co., Ltd.Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.Multistix® 8 SG Reagent Strips — Siemens Healthcare Diagnostics Inc.Moore Medical — MOORE MEDICAL LLCRapid Response — BTNX IncMission Urinalysis Reagent Strips — Acon Laboratories, Inc.TECO DIAGNOSTICS — TECO DIAGNOSTICSGoldN Easy to Use Vaginal pH Test — NOVODX CorporationAccustrip 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 DIAGNOSTICSRapid Response — BTNX IncDiscover Multi-Drug 8 Drugs Rapid Test Cup (Urine) — Hangzhou AllTest Biotech Co., Ltd.Discover Multi-Drug Test Cup — Hangzhou AllTest Biotech Co., Ltd.Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.Walgreens — WALGREEN CO.CLINITEK Novus® 10 Urinalysis Cassette 450 — Siemens Healthcare Diagnostics Inc.Mission Urinalysis Reagent Strips — Acon Laboratories, Inc.CARDINAL HEALTH — Cardinal Health 200, LLC

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.
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
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

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