Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
US Nationwide distribution in the states of TX, GA, CA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1263-2026