FDA device listing

EOSIN Y,EOSIN Y ALCHOLIC SOLUTION

FDA device listing 1855280070 · POLYSCIENCES, INC.

Key facts

Proprietary names EOSIN Y,EOSIN Y ALCHOLIC SOLUTION
Owner/operator POLYSCIENCES, INC.
Owner/operator number 2518071
Product codes HYB
Device names HYB - Eosin Y
Device class Class I
Classification regulations (21 CFR) 864.1850
Review panels Hematology
Registered establishments POLYSCIENCES, INC.
Establishment registrations 2518071
FEI numbers 2518071
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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