MAUDE manufacturer profile

LUMINEX CORPORATION · QJR

MAUDE profile for Reagents, 2019-Novel Coronavirus Nucleic Acid

Key facts

Manufacturer LUMINEX CORPORATION
Manufacturer group LUMINEX CORPORATION
Product code QJR
Product code name Reagents, 2019-Novel Coronavirus Nucleic Acid

At a glance

  • 100–999 MAUDE reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Insufficient Information, Incorrect, Inadequate or Imprecise Result or Readings, False Positive Result, False Negative Result, No Apparent Adverse Event, Defective Component, No Known Impact Or Consequence To Patient 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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