MAUDE manufacturer profile

MERIDIAN BIOSCIENCE INC. · OOI

MAUDE profile for Real Time Nucleic Acid Amplification System

Key facts

Manufacturer MERIDIAN BIOSCIENCE INC.
Manufacturer group MERIDIAN BIOSCIENCE INC
Product code OOI
Product code name Real Time Nucleic Acid Amplification System

At a glance

  • 10–99 MAUDE reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Temperature Problem, Insufficient Information, Output Problem, No Apparent Adverse Event, Nonstandard Device, Difficult to Open or Close, Melted Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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