FDA device listing

NUCLEAR FAST RED,Reticulin/Nuclear Fast Red Stain

FDA device listing 1214851555 · BIOGENEX LABORATORIES INC.

Key facts

Proprietary names NUCLEAR FAST RED,Reticulin/Nuclear Fast Red Stain
Owner/operator BIOGENEX LABORATORIES INC.
Owner/operator number 2936532
Product codes HZF
Device names HZF - Nuclear Fast Red
Device class Class I
Classification regulations (21 CFR) 864.1850
Review panels Hematology
Registered establishments BIOGENEX LABORATORIES INC.
Establishment registrations 3008776165
FEI numbers 2936532
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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