FDA product code GSH: Antisera, All Types, Listeria Monocytogenes

GSH is the FDA product code for antisera, all types, listeria monocytogenes. It is a Class I device, regulated under 21 CFR 866.3355 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GSH. The average 510(k) review took 49 days (median 49).

Classification

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

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Most recent GSH clearances

Recalls for GSH devices

openFDA lists no recalls for product code GSH.

Frequently asked questions

What is FDA product code GSH?

GSH is the FDA product code for antisera, all types, listeria monocytogenes. It is a Class I device, regulated under 21 CFR 866.3355 and reviewed by the Microbiology panel.

What device class is GSH?

Class I, regulation 21 CFR 866.3355. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).

Which companies have the most GSH clearances?

Volu Sol Medical Industries (1).

Next steps

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