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Electrode, Ion Specific, Urea Nitrogen

FDA product code CDS · Class 2 · Clinical Chemistry

80
Registered devices
7
Adverse events
1
Recalls
15
510(k) clearances

Devices with this code

STAT PROFILE — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONNova — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONStat Profile — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONStat Profile — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONNOVA/STAT PROFILE — NOVA BIOMEDICAL CORPORATIONGENCHEM™Electrode, Ion Specific, Urea Nitrogen (BUN) reagent — GENCHEM INCSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONNOVA — NOVA BIOMEDICAL CORPORATIONNova — NOVA BIOMEDICAL CORPORATION

Recent recalls

DateFirmReason
2016-10-31Roche Diagnostics Operations, Inc.Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected

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