LSOClass II

Dna-Reagents, Cytomegalovirus

21 CFR 866.3175 / Microbiology

LSO is the FDA product code for Dna-Reagents, Cytomegalovirus, a class II device type, regulated under 21 CFR 866.3175. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: LSO
Device name: Dna-Reagents, Cytomegalovirus
Regulation: 21 CFR 866.3175
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LSO.

Recent clearances

Product code LSO

FDA records hold no clearances under product code LSO.

Recent recalls

Product code LSO

Z-1039-04In vitro diagnostic test kit may produce false negative clinical results.Digene Corp / initiated 2004-05-28 / 206 kits

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)