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P2psa

P2psa is a medical device type in the Unknown 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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P2psa
Unknown Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OYA

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Class 3

21 CFR

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Unknown

Device Characteristics

No

No

No

Not Eligible

Definition

Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)