FDA device listing

IODINE GRAM, LUGOLS

FDA device listing 1840108321 · MilliporeSigma

Key facts

Proprietary names IODINE GRAM, LUGOLS
Owner/operator MilliporeSigma
Owner/operator number 1216103
Product codes IAM
Device names IAM - Solution, Lugol'S
Device class Class I
Classification regulations (21 CFR) 864.4010
Review panels Pathology
Registered establishments EMD MILLIPORE CORPORATION
Establishment registrations 3009432145
FEI numbers 2244894
Establishment operations Complaint File Establishment
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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