DeviceClearance

Product code PHJ— Hematology

IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST

Classification name
System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
Device class
Class 2
Regulation
21 CFR 864.7280
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PHJ under 21 CFR 864.7280, via openFDA

Market context for product code PHJ

FDA has cleared 1 device under product code PHJ, all in 2014, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PHJ

Recent clearances under product code PHJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.