FDA device listing

Veracyte FFPE RNA Extraction Kit

FDA device listing 1946055030 · Veracyte, Inc.

Key facts

Proprietary names Veracyte FFPE RNA Extraction Kit
Owner/operator Veracyte, Inc.
Owner/operator number 10035252
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 Veracyte, Inc.
Establishment registrations 3007808978
FEI numbers 3007808978
Establishment operations Complaint File Establishment, Specification Developer
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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