In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1188-2024