FDA product code DEF: Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control

DEF is the FDA product code for alpha-2-hs-glycoprotein, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5425 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DEF. The average 510(k) review took 125 days (median 125).

Classification

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

Top DEF applicants

Most recent DEF clearances

Recalls for DEF devices

openFDA lists no recalls for product code DEF.

Frequently asked questions

What is FDA product code DEF?

DEF is the FDA product code for alpha-2-hs-glycoprotein, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5425 and reviewed by the Immunology panel.

What device class is DEF?

Class I, regulation 21 CFR 866.5425. Typical premarket route: 510(k) exempt.

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

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

Which companies have the most DEF clearances?

Seradyn, Inc. (1).

Next steps

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