FDA device listing

EOSIN STAIN 5% SOLN,EOSIN Y SOLUTION ALCOHOLIC,EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE,EOSIN Y SOLUTION AQUEOUS

FDA device listing 1328515828 · MilliporeSigma

Key facts

Proprietary names EOSIN STAIN 5% SOLN,EOSIN Y SOLUTION ALCOHOLIC,EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE,EOSIN Y SOLUTION AQUEOUS
Owner/operator MilliporeSigma
Owner/operator number 1216103
Product codes HYB
Device names HYB - Eosin Y
Device class Class I
Classification regulations (21 CFR) 864.1850
Review panels Hematology
Registered establishments EMD MILLIPORE CORPORATION, SIGMA-ALDRICH CORP., SIGMA-ALDRICH MANUFACTURING, LLC-H&H
Establishment registrations 1937990, 1000138378, 3009432145
FEI numbers 1937990, 2244894, 1000138378
Establishment operations Complaint File Establishment, Contract Manufacturer, Manufacturer, Repackager/Relabeler
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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