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Babesia Spp. Serological Reagents

Babesia Spp. Serological Reagents 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
Multi-Country Intelligence
Babesia Spp. Serological Reagents
Unknown Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QIN

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Class N

21 CFR

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Unknown

Device Characteristics

No

No

No

Not Eligible

Definition

Tests or reagents used to detect IgG and/or IgM antibodies to Babesia spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Babesia spp. in patients suspected of exposure.