FDA-Device2015-07-08Class II
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.
Axis-Shield Diagnostics, Ltd.
Hazard
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
Sold states
Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.
Affected count
52 kits + 75 kits Beckman Coulter Brand OUS
Manufactured in
The Technology Park, Luna Place, Dundee, United Kingdom
Products
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1946-2015Don't want to check this manually?
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