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Test, Factor V Leiden Mutations, Genomic Dna Pcr

FDA product code NPQ · 5 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.7280
Review panel
PA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2007-02-07 – 2011-06-01

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.

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