2 results
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12ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
FDA Enforcement
Class III
·Terminated·Horiba Instruments, Inc dba Horiba Medical·February 12, 2014
Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
FDA Enforcement
Class III
·Terminated·Randox Laboratories·June 7, 2017