FDA-Device2025-01-29Class II
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Randox Laboratories, Limited
Hazard
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Sold states
US Nationwide distribution Including PR.
Affected count
33 kits
Manufactured in
Ardmore; 55 The Diamond Road, Crumlin, United Kingdom
Products
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1018-2025Don't want to check this manually?
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