FDA-Device2014-12-31Class II
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Ortho-Clinical Diagnostics
Hazard
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.
Sold states
Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
Affected count
USA: 380 units, Foreign: 155 units
Manufactured in
513 Technology Blvd, Rochester, NY, United States
Products
VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0848-2015Don't want to check this manually?
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