FDA product code GOB: Antigens, Ha (Including Ha Control), Adenovirus 1-33

GOB is the FDA product code for antigens, ha (including ha control), adenovirus 1-33. It is a Class I device, regulated under 21 CFR 866.3020 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GOB. The average 510(k) review took 77 days (median 77).

Classification

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Most recent GOB clearances

Recalls for GOB devices

openFDA lists no recalls for product code GOB.

Frequently asked questions

What is FDA product code GOB?

GOB is the FDA product code for antigens, ha (including ha control), adenovirus 1-33. It is a Class I device, regulated under 21 CFR 866.3020 and reviewed by the Microbiology panel.

What device class is GOB?

Class I, regulation 21 CFR 866.3020. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 77 days from receipt to decision (median 77).

Which companies have the most GOB clearances?

Mercia Diagnostics , Ltd. (1).

Next steps

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