FDA-Device2017-07-12Class II
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
JAS Diagnostics Inc.
Hazard
May result in elevated platelet backgrounds during routine startup/background checks.
Sold states
AL, AR, CA, FL, GA, IA, IN, LA, MA, MN, MO, NC, NE, NY, SC, TN, TX, and Puerto Rico United Arab Emirates, Bolivia, Republic of C¿te dIvoire, Colombia, Costa Rica, Ecuador, Egypt, Indonesia, Iraq, Italy, Korea, Mexico, Russia, Philippines, Slovenia, Tunisia, Venezuela, and Vietnam
Affected count
14,064
Manufactured in
14100 NW 57th Ct, N/A, Miami Lakes, FL, United States
Products
Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2656-2017Don't want to check this manually?
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