FDA product code DGB: Seminal Fluid, Antigen, Antiserum, Control

DGB is the FDA product code for seminal fluid, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5800 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under DGB. The average 510(k) review took 61 days (median 61).

Classification

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Recalls for DGB devices

openFDA lists no recalls for product code DGB.

Frequently asked questions

What is FDA product code DGB?

DGB is the FDA product code for seminal fluid, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5800 and reviewed by the Hematology panel.

What device class is DGB?

Class I, regulation 21 CFR 866.5800. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 61 days from receipt to decision (median 61).

Which companies have the most DGB clearances?

Zygotek Systems, Inc. (1).

Next steps

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