FDA-Device2019-07-10Class II
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.
Siemens Healthcare Diagnostics, Inc.
Hazard
A steady upward trend in blank (u) absorbance was observed
Sold states
Worldwide distribution.
Affected count
3,386
Manufactured in
500 Gbc Dr Ms 514, N/A, Newark, DE, United States
Products
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1913-2019Don't want to check this manually?
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