CLSI H59-A

Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline.

Body

CLSI

Number

CLSI H59-A

FDA recognition no.

7-220

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Section 9.4 Methods That a Laboratory May Use to Determine the Threshold for Exclusion of Venous Thromboembolism. Appendix - Table A1 Example of the Level of Supporting Evidence Used to Discriminate Between "Aid in Diagnosis of VTE" vs "Exclusion of VTE" Product "Indications for Use" Claims.

Scope source: FDA 认可共识标准库

Laboratories covering this standard