FDA-Device2016-05-04Class II
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
Jas Diagnostics/Drew Scientific
Hazard
The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.
Sold states
Worldwide Distribution - US Distribution including the states of : AL, AR, CA, FL, GA, IA, IN, KS, KY, LA, MA, MN, MO, MS, NC, NE, NY, SC, TN, and TX. and to the countries of : Bolivia, Cairo, Columbia, Ecuador, Italy, Moscow, Netherlands, Pakistan, Peru, Slovenia, Spain, and Venezuela.
Affected count
7,691
Manufactured in
14100 NW 57th Ct, N/A, Miami Lakes, FL, United States
Products
Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1576-2016Don't want to check this manually?
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