FDA product code DEG: Lactoferrin, Antigen, Antiserum, Control

DEG is the FDA product code for lactoferrin, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5570 and reviewed by the Immunology panel. FDA has cleared 8 510(k) submissions under DEG, from 4 different applicants. The average 510(k) review took 82 days (median 78). FDA has posted 1 recall for DEG devices, 1 initiated in the last five years.

Classification

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

Top DEG applicants

Most recent DEG clearances

Recalls for DEG devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2023-03-27.

Frequently asked questions

What is FDA product code DEG?

DEG is the FDA product code for lactoferrin, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5570 and reviewed by the Immunology panel.

What device class is DEG?

Class I, regulation 21 CFR 866.5570. Typical premarket route: 510(k) exempt.

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

Across 8 cleared submissions the average was 82 days from receipt to decision (median 78).

Which companies have the most DEG clearances?

Techlab, Inc. (4); Touch Scientific, Inc. (2); Techlab Inc., Corporate Research Center (1); Mackeen Consultants, Ltd. (1).

Have DEG devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2023-03-27.

Next steps

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