Clia Waived Medical Products

Clia Waived Medical Products

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Clia Waived Defined: CLIA refers to Clinical Laboratory Improvement Amendments. These amendments were passed by the Congress way back in 1988. These laws stipulate that laboratory testing procedures should ensure timeliness, accuracy and dependability irrespective of the location of the tests.

Every laboratory and home test has its own unique requirements. Certain tests can be highly complex and may require specialized equipment. If these tests satisfy certain conditions they can be exempt or waived from all regulatory procedures. In other words, these tests are cleared by FDA and can be performed at home. Most of these tests are very simple to carry out and use standardized equipment, which makes chances of an inaccuracy impossible. Such tests are referred to as a CLIA waived.

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