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SIEMENS 510(k) Summary NV3021 Dimension Vista VIBI2 NV0212 This summary of 51 0(k) safety and effectiveness information is submitted in accordance with the requirements of SODA 1990 and 21 CFR 807.92.
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Dimension Vista VIBI2 is a software application used for clinical chemistry and immunoassay testing.
Medical laboratories and healthcare facilities that perform clinical chemistry and immunoassay testing are required to use Dimension Vista VIBI2.
Dimension Vista VIBI2 can be filled out by trained laboratory technicians or healthcare professionals using the software interface provided.
The purpose of Dimension Vista VIBI2 is to accurately analyze and report clinical chemistry and immunoassay test results.
Dimension Vista VIBI2 must report test results, patient information, and any relevant laboratory data.
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