FDA device listing

Amicon Ultra - 15,Amicon Ultra - 4,Centrifree

FDA device listing 1689998872 · MilliporeSigma

Key facts

Proprietary names Amicon Ultra - 15,Amicon Ultra - 4,Centrifree
Owner/operator MilliporeSigma
Owner/operator number 1216103
Product codes JJH
Device names JJH - Clinical Sample Concentrator
Device class Class I
Classification regulations (21 CFR) 862.2310
Review panels Clinical Chemistry
Registered establishments Merck Millipore Ltd., MILLIPORE S.A.S
Establishment registrations 8020892, 9612003
FEI numbers 1000532580, 3002807666
Establishment operations Foreign Exporter, 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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