PHJ

System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

Product code

PHJ

Device name

System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

Device class

Class 2

21 CFR

21 CFR 864.7280

Medical specialty

Hematology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

A multiplex genotying test system intended for the qualitative detection and identification of specific thrombophilia related gene mutations from genomic DNA by genomic amplification and mass spectrometry. It is intended as an aid in diagnosis of patients with suspected thrombophilia.

Definition text from the FDA device classification database (U.S. federal government work, public domain).