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CLIA-88 |
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Those regulations, the Clinical Laboratory Improvement Amendments of 1988 ( The Clinical Laboratory Improvement Amendments of 1988 (CLIA) law established provisions for categorizing a test as waived. In the United States, clinical diagnostics systems must gain FDA approval and comply with the regulations set forth by the Clinical Laboratory Improvement Amendments of 1988 (CLIA)," explains Cerqueira. |
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