inforMED
NPQClass II

Test, Factor V Leiden Mutations, Genomic Dna Pcr

Hematology · 21 CFR 864.7280

In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

MDR events25All time
Recalls14All time
Registered firms10Currently listed
510(k) clearances6All time

Recalls

14 recall events for this product code

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