FDA device listing

Nerl Hematology Reagents 15

FDA device listing 1893816346 · Epredia Holdings Ltd.

Key facts

Proprietary names Nerl Hematology Reagents 15
Owner/operator Epredia Holdings Ltd.
Owner/operator number 10062642
Product codes KQC
Device names KQC - Stains, Hematology
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 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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