# System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
> **Product code: PHJ** · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.7280
## Classification
- **FDA Product Code:** PHJ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.7280
- **Review panel:** PA
- **Medical specialty:** Hematology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PHJ)
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