FDA product code GQR: Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4

GQR is the FDA product code for antigens, ha (including ha control), parainfluenza virus 1-4. It is a Class I device, regulated under 21 CFR 866.3400 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GQR. The average 510(k) review took 20 days (median 20).

Classification

Compare with all 510(k) review times · Search every GQR clearance

Top GQR applicants

Most recent GQR clearances

Recalls for GQR devices

openFDA lists no recalls for product code GQR.

Frequently asked questions

What is FDA product code GQR?

GQR is the FDA product code for antigens, ha (including ha control), parainfluenza virus 1-4. It is a Class I device, regulated under 21 CFR 866.3400 and reviewed by the Microbiology panel.

What device class is GQR?

Class I, regulation 21 CFR 866.3400. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code GQR?

Across 1 cleared submissions the average was 20 days from receipt to decision (median 20).

Which companies have the most GQR clearances?

Dutchland Laboratories, Inc. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code GQR
• Run a recall and safety report across every GQR manufacturer
• Watch product code GQR for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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