FDA product code GSS: Antisera, Fluorescent, Pseudomonas Aeruginosa

GSS is the FDA product code for antisera, fluorescent, pseudomonas aeruginosa. It is a Class II device, regulated under 21 CFR 866.3415 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GSS. The average 510(k) review took 125 days (median 125).

Classification

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

Top GSS applicants

Most recent GSS clearances

Recalls for GSS devices

openFDA lists no recalls for product code GSS.

Frequently asked questions

What is FDA product code GSS?

GSS is the FDA product code for antisera, fluorescent, pseudomonas aeruginosa. It is a Class II device, regulated under 21 CFR 866.3415 and reviewed by the Microbiology panel.

What device class is GSS?

Class II, regulation 21 CFR 866.3415. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 125 days from receipt to decision (median 125).

Which companies have the most GSS clearances?

Symbiosis Corp. (1).

Next steps

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