MAUDE manufacturer profile

BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. · GNX

MAUDE profile for Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

Key facts

Manufacturer BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
Manufacturer group BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
Product code GNX
Product code name Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

At a glance

  • 100–999 MAUDE reports
  • 1–9 Injury reports
  • 100–999 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, False Positive Result, Device Contamination with Chemical or Other Material, No Consequences Or Impact To Patient, False Negative Result, Device Markings/Labelling Problem 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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