FDA product code MXB: Test, Vaginal, Bacterial Sialidase

MXB is the FDA product code for test, vaginal, bacterial sialidase. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Clinical Chemistry panel. FDA has cleared 2 510(k) submissions under MXB. The average 510(k) review took 104 days (median 104). FDA has posted 1 recall for MXB devices, 1 initiated in the last five years.

Classification

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

Top MXB applicants

Most recent MXB clearances

Recalls for MXB devices

1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-01-09.

Frequently asked questions

What is FDA product code MXB?

MXB is the FDA product code for test, vaginal, bacterial sialidase. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Clinical Chemistry panel.

What device class is MXB?

Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.

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

Across 2 cleared submissions the average was 104 days from receipt to decision (median 104).

Which companies have the most MXB clearances?

Gryphus Diagnostics, LLC (2).

Have MXB devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2024-01-09.

Next steps

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