FDA product code GQQ: Antisera, Hai, Parainfluenza Virus 1-4

GQQ is the FDA product code for antisera, hai, 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 GQQ. The average 510(k) review took 17 days (median 17).

Classification

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Most recent GQQ clearances

Recalls for GQQ devices

openFDA lists no recalls for product code GQQ.

Frequently asked questions

What is FDA product code GQQ?

GQQ is the FDA product code for antisera, hai, 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 GQQ?

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

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

Across 1 cleared submissions the average was 17 days from receipt to decision (median 17).

Which companies have the most GQQ clearances?

Northeast Biomedical Labs., Inc. (1).

Next steps

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