FDA device listing

Discovery Patch Sweat Collection System

FDA device listing 1266972838 · Epicore Biosystems, Inc.

Key facts

Proprietary names Discovery Patch Sweat Collection System
Owner/operator Epicore Biosystems, Inc.
Owner/operator number 10082474
Product codes NNI
Device names NNI - Container, Specimen, Non-Sterile
Device class Class I
Classification regulations (21 CFR) 864.3250
Review panels Pathology
Registered establishments EPICORE BIOSYSTEMS, INC.
Establishment registrations 3019946761
FEI numbers 3019946761
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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