MAUDE manufacturer profile

LEICA BIOSYSTEMS NEWCASTLE LTD · NJT

MAUDE profile for Immunohistochemistry Reagents And Kits

Key facts

Manufacturer LEICA BIOSYSTEMS NEWCASTLE LTD
Manufacturer group LEICA BIOSYSTEMS
Product code NJT
Product code name Immunohistochemistry Reagents And Kits

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Insufficient Information, Manufacturing, Packaging or Shipping Problem, Device Operates Differently Than Expected, 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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