FDA product code GNO: Antisera, Cf, Coxsackievirus A 1-24, B 1-6

GNO is the FDA product code for antisera, cf, coxsackievirus a 1-24, b 1-6. It is a Class I device, regulated under 21 CFR 866.3145 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GNO. The average 510(k) review took 94 days (median 94).

Classification

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

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Recalls for GNO devices

openFDA lists no recalls for product code GNO.

Frequently asked questions

What is FDA product code GNO?

GNO is the FDA product code for antisera, cf, coxsackievirus a 1-24, b 1-6. It is a Class I device, regulated under 21 CFR 866.3145 and reviewed by the Microbiology panel.

What device class is GNO?

Class I, regulation 21 CFR 866.3145. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 94 days from receipt to decision (median 94).

Which companies have the most GNO clearances?

Hillcrest Biologicals (1).

Next steps

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