FDA device listing

Alinity c Uric Acid Reagent Kit,Uric Acid

FDA device listing 1502685627 · Thermo Fisher Scientific

Key facts

Proprietary names Alinity c Uric Acid Reagent Kit,Uric Acid
Owner/operator Thermo Fisher Scientific
Owner/operator number 2517925
Product codes KNK
Device names KNK - Acid, Uric, Uricase (Colorimetric)
Device class Class I
Classification regulations (21 CFR) 862.1775
Review panels Clinical Chemistry
Registered establishments Fisher Diagnostics
Establishment registrations 1181121
FEI numbers 1181121
Establishment operations U.S. Manufacturer of Export Only Devices
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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