Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840
The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OR, PA, PR, RI, SD, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Chile, Italy, Switzerland.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0836-2022