FDA device listing

Anti-Parainfluenza Viruses Pool ELISA (IgG)

FDA device listing 1263934562 · EUROIMMUN US Inc.

Key facts

Proprietary names Anti-Parainfluenza Viruses Pool ELISA (IgG)
Owner/operator EUROIMMUN US Inc.
Owner/operator number 10025673
Product codes GQT
Device names GQT - Antisera, Cf, Parainfluenza Virus 1-4
Device class Class I
Classification regulations (21 CFR) 866.3400
Review panels Microbiology
Registered establishments EUROIMMUN US INC.
Establishment registrations 3007118747
FEI numbers 3007118747
Establishment operations Complaint File Establishment
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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