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This guideline provides recommendations for assessing clinically equivalent performance for additional similar-matrix specimen types and suitable performance for dissimilar-matrix specimen types, such that the laboratory does not necessarily need to repeat the full measurement procedure validation for each specimen type. The recommendations in this guideline apply to both quantitative measurement procedures and qualitative examinations.

Product Details

Edition:

1st

Published:

12/01/2019

ISBN(s):

9781684400621

Number of Pages:

82

File Size:

1 file , 12 MB