FDA product code LQG: Dna-Reagents, Mycoplasma Spp.

LQG is the FDA product code for dna-reagents, mycoplasma spp.. It is a Class I device, regulated under 21 CFR 866.3375 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under LQG. The average 510(k) review took 139 days (median 139). FDA has posted 1 recall for LQG devices, 1 initiated in the last five years.

Classification

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

Top LQG applicants

Most recent LQG clearances

Recalls for LQG devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.

Frequently asked questions

What is FDA product code LQG?

LQG is the FDA product code for dna-reagents, mycoplasma spp.. It is a Class I device, regulated under 21 CFR 866.3375 and reviewed by the Microbiology panel.

What device class is LQG?

Class I, regulation 21 CFR 866.3375. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 139 days from receipt to decision (median 139).

Which companies have the most LQG clearances?

Gen-Probe, Inc. (1).

Have LQG devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.

Next steps

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