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Most LDTs are expected to require a 510(k) or de novo , but if the type of submission is unknown, the regulatory pathway/strategy should first be determined

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For the short-term and 4 h experiments, trophozoite stage parasites (2630 h) of the 3D7 and Dd2 strains expressing hGrx1-roGFP2 were magnetically enriched initially (Miltenyi Biotec, Germany) [62], [71] then counted using the improved Neubauer hemocytometer (Brand GmbH, Germany) and returned to cell culture (at 5.010 3 trophozoites/l) for at least 2 h to recover

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