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Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

FDA product code CDM · Class 1 · Clinical Chemistry

155
Registered devices
21
Adverse events
1
Recalls
9
510(k) clearances

Devices with this code

Accutest — JANT PHARMACAL CORPORATIONTECO DIAGNOSTICS — TECO DIAGNOSTICSTECO 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.AUTION™ MAX AX-4022 Analyzer — ARKRAY USA, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Urine Chemistry Strips — Urit Medical Electronic Co., Ltd.Areta 10 Parameters Urinalysis Reagent Strips （50 tests kit） — EASY HEALTHCARE CORPORATIONTECO DIAGNOSTICS — TECO DIAGNOSTICSTECO DIAGNOSTICS — TECO DIAGNOSTICSAutomatic Urine Analyzer — Urit Medical Electronic Co., Ltd.Multistix® 10 SG Reagent Strips — Siemens Healthcare Diagnostics Inc.Areta 10 Parameters Urinalysis Reagent Strips (100 tests kit） — EASY HEALTHCARE CORPORATIONAUTION™ Sticks 10EA Test Strips — ARKRAY USA, INC.Urine Reagent Strips — Urit Medical Electronic Co., Ltd.Medline — MEDLINE INDUSTRIES, INC.Areta pH Urinalysis Reagent Strips (100 tests kit） — EASY HEALTHCARE CORPORATIONTECO DIAGNOSTICS — TECO DIAGNOSTICSMission U120 Touch Urine Analyzer — Acon Laboratories, Inc.Moore Medical — MOORE MEDICAL LLC

Recent recalls

DateFirmReason
2018-06-22Clarity Diagnostics LlcClarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of

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