CLSI MM17

Verification and Validation of Multiplex Nucleic Acid Assays

Body: CLSI
Number: CLSI MM17
FDA recognition no.: 7-289

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Chapter 2.4 Validation and Verification Protocols Chapter 2.5 Analytical Validation of a Laboratory-Developed Test Chapter 2.6 Analytical Validation of a Modified In Vitro Diagnostic Assay Chapter 2.7 Verification of an In Vitro Diagnostic Assay

Scope source: FDA 认可共识标准库

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