FDA-Device2018-05-16Class II
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Randox Laboratories Ltd.
Hazard
Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
Sold states
US Nationwide Distribution in the states of West Virginia and Puerto Rico
Affected count
8
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1631-2018Don't want to check this manually?
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