MAUDE manufacturer profile

INFINITY BIOLOGIX LLC, DBA SAMPLED · QJR

MAUDE profile for Reagents, 2019-Novel Coronavirus Nucleic Acid

Key facts

Manufacturer INFINITY BIOLOGIX LLC, DBA SAMPLED
Manufacturer group INFINITY BIOLOGIX LLC DBA SAMPLED
Product code QJR
Product code name Reagents, 2019-Novel Coronavirus Nucleic Acid

At a glance

  • 1–9 MAUDE reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Incorrect, Inadequate or Imprecise Result or Readings, Viral Infection, Output Problem, Insufficient Information 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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