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Dye-Indicator, Ph (Urinary, Non-Quantitative)
FDA product code CEN · Class 1 · Clinical Chemistry
245
Registered devices
4
Adverse events
5
Recalls
11
510(k) clearances
Devices with this code
Accutest — JANT PHARMACAL CORPORATIONRapid Response — BTNX IncTECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSYodoc 10 — DFI CO.,LTDTECO DIAGNOSTICS — TECO DIAGNOSTICSMulti-Drug 14 Drugs Rapid Test Cup — Hangzhou AllTest Biotech Co., Ltd.Urine Reagent Strips, 10-parameter — LW SCIENTIFIC, INC.URINE REAGENT STRIPS — Urit Medical Electronic Co., Ltd.Urine Reagent Strips — Urit Medical Electronic Co., Ltd.TECO DIAGNOSTICS — TECO DIAGNOSTICSAlltest Multi-Drug 18 Drugs Urine Test Cup — Hangzhou AllTest Biotech Co., Ltd.AUTION™ MAX AX-4022 Analyzer — ARKRAY USA, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Urine Chemistry Strips — Urit Medical Electronic Co., Ltd.TECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSAIMSTRIP US-4 — GERMAINE LABORATORIES, INCMission Urinalysis Reagent Strips — Acon Laboratories, Inc.TECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSAutomatic Urine Analyzer — Urit Medical Electronic Co., Ltd.Multistix® 10 SG Reagent Strips — Siemens Healthcare Diagnostics Inc.Discover Multi-Drug Test Cup — Hangzhou AllTest Biotech Co., Ltd.
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. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 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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