FDA device listing

LIPASE ENVOY, REF LPSL-0850-NA,Lipase SL, 4 x 9.2 mL, REF LPSL-0230-NA

FDA device listing 1726830460 · VitalScientific

Key facts

Proprietary names LIPASE ENVOY, REF LPSL-0850-NA,Lipase SL, 4 x 9.2 mL, REF LPSL-0230-NA
Owner/operator VitalScientific
Owner/operator number 10090892
Product codes CHI
Device names CHI - Lipase-Esterase, Enzymatic, Photometric, Lipase
Device class Class I
Classification regulations (21 CFR) 862.1465
Review panels Clinical Chemistry
Registered establishments VitalScientific
Establishment registrations 3007662974
FEI numbers 3007662974
Establishment operations 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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