PHJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7280
- Medical specialty
- Hematology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST (K132978) | Sequenom, Inc. | 2014-06-13 |
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