FDA-Device2018-03-28Class II
Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
Epigenomics Ag
Hazard
The diagnostic test kit may produce invalid test runs which may delay test results.
Sold states
Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.
Affected count
200
Manufactured in
Geneststr. 5, N/A, Berlin, N/A, Germany
Products
Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1077-2018Don't want to check this manually?
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