FDA-Device2014-12-24Class II
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
Siemens Healthcare Diagnostics, Inc.
Sold states
Worldwide Distribution: US distribution in states of: CO, FL, MN, MT, and NY; and countries of: Algeria, Argentina, Bolivia, Brazil, Bulgaria, Chile, Columbia, Czech Republic, Ecuador, Egypt, Germany, Hungary, India, Italy, Lithuania, Latvia, Pakistan, Poland, Romania, Russian Fed., Serbia, South Africa, Slovakia, Thailand, Tunisia, and Uruguay.
Affected count
3,622 kits (3,572 domestic and 50 internationally)
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0801-2015Don't want to check this manually?
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