FDA device listing

Buffered Wright Stain,Modified Wright Stain Pack,Wright Stain

FDA device listing 1575376817 · Epredia Holdings Ltd.

Key facts

Proprietary names Buffered Wright Stain,Modified Wright Stain Pack,Wright Stain
Owner/operator Epredia Holdings Ltd.
Owner/operator number 10062642
Product codes IAF
Device names IAF - Wright'S Stain
Device class Class I
Classification regulations (21 CFR) 864.1850
Review panels Hematology
Registered establishments RICHARD-ALLAN SCIENTIFIC LLC
Establishment registrations 1831638
FEI numbers 1831638
Establishment operations Contract Manufacturer, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

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

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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