FDA-Device2014-05-07Class II
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.
Alfa Wassermann, Inc.
Hazard
Extremely low absorbance readings.
Sold states
US Nationwide Distribution
Affected count
SA1047 lot F3609: 146; RX1047 lot F3610: 53
Manufactured in
4 Henderson Dr, West Caldwell, NJ, United States
Products
Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1530-2014Don't want to check this manually?
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