FDA-Device2020-05-20Class II
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
Ortho-Clinical Diagnostics
Hazard
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
Sold states
US Nationwide distribution.
Affected count
N/A
Manufactured in
513 Technology Blvd, N/A, Rochester, NY, United States
Products
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1930-2020Don't want to check this manually?
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