FDA product code DGQ: Whole Blood Plasma, Antigen, Antiserum, Control

DGQ is the FDA product code for whole blood plasma, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5700 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under DGQ. The average 510(k) review took 99 days (median 99).

Classification

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

Top DGQ applicants

Most recent DGQ clearances

Recalls for DGQ devices

openFDA lists no recalls for product code DGQ.

Frequently asked questions

What is FDA product code DGQ?

DGQ is the FDA product code for whole blood plasma, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5700 and reviewed by the Hematology panel.

What device class is DGQ?

Class I, regulation 21 CFR 866.5700. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 99 days from receipt to decision (median 99).

Which companies have the most DGQ clearances?

Diagnostica, Inc. (1).

Next steps

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