Report copyright - 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION …OVA1 . Within-run : n . Total : Between-run (Mean) SD %CV: SD %CV: SD %CV : 1 . 80 : 2.74 . 2.4 : 0.011. 0.065: 0.4 . 0.091: 3.3 . 2
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