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Classification

Classification

KMLTTB has adopted a risk based classification as per the Global Harmonization Taskforce IVD classification guidelines as identified below:

CLASSIFICATION LEVEL OF RISK EXAMPLES
Class 1 IVD no public health risk or low personal risk Clinical Chemistry Analyser , prepared selective culture media
Class 2 IVD low public health risk or moderate personal risk Vitamin B12, Pregnancy self testing, Anti-Nuclear Antibody, Urine test strips
Class 3 IVD moderate public health risk or high personal risk Blood glucose self testing, HLA typing, PSA screening, Rubella
Class 4 IVD high public health risk or High personal risk HIV Blood donor screening, HIV Blood

Note: The rules for each class are spelt out in the policy document.

 

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