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Automated Occult Blood Analyzer

Automated Occult Blood Analyzer 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
Multi-Country Intelligence
Automated Occult Blood Analyzer
Hematology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OOX

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Class 2

21 CFR 864.6550

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Hematology

Device Characteristics

No

No

No

Eligible

Definition

The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.