FDA product code LSO: Dna-Reagents, Cytomegalovirus
LSO is the FDA product code for dna-reagents, cytomegalovirus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel. Devices under LSO reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for LSO devices.
Classification
| Field | Value |
|---|---|
| Device name | Dna-Reagents, Cytomegalovirus |
| Device class | Class II |
| Regulation | 21 CFR 866.3175 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for LSO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-05-28.
Frequently asked questions
What is FDA product code LSO?
LSO is the FDA product code for dna-reagents, cytomegalovirus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel.
What device class is LSO?
Class II, regulation 21 CFR 866.3175. Typical premarket route: 510(k).
Have LSO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-05-28.
Next steps
- Run an FDA pathway report with predicate devices for product code LSO
- Run a recall and safety report across every LSO manufacturer
- Watch product code LSO 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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