FDA device listing

Lipids Strip

FDA device listing 1437355605 · Sanzay Corporation - Integrated Diagnostics Group

Key facts

Proprietary names Lipids Strip
Owner/operator Sanzay Corporation - Integrated Diagnostics Group
Owner/operator number 10026301
Product codes CFB
Device names CFB - Chromatographic Derivative, Total Lipids
Device class Class I
Classification regulations (21 CFR) 862.1470
Review panels Clinical Chemistry
Registered establishments SANZAY CORPORATION -
Establishment registrations 3005146313
FEI numbers 3005146313
Establishment operations 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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