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Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Hematology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NPR

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Class 2

21 CFR 864.7280

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Hematology

Device Characteristics

No

No

No

Not Eligible

Definition

In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.