FDA product code DGX: Ng1m(A), Antigen, Antiserum, Control

DGX is the FDA product code for ng1m(a), antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5065 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DGX. The average 510(k) review took 91 days (median 91).

Classification

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

Top DGX applicants

Most recent DGX clearances

Recalls for DGX devices

openFDA lists no recalls for product code DGX.

Frequently asked questions

What is FDA product code DGX?

DGX is the FDA product code for ng1m(a), antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5065 and reviewed by the Immunology panel.

What device class is DGX?

Class I, regulation 21 CFR 866.5065. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 91 days from receipt to decision (median 91).

Which companies have the most DGX clearances?

Genetic Testing Institute (1).

Next steps

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