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11-Dehydro Thromboxane B2 Kit, Urinary

11-Dehydro Thromboxane B2 Kit, Urinary 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
11-Dehydro Thromboxane B2 Kit, Urinary
Hematology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OBW

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Class 2

21 CFR 864.5700

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Hematology

Device Characteristics

No

No

No

Eligible

Definition

The test kit is an enzyme-linked immunoassay (elisa) to determine levels of 11-dehydro thromboxane b2 (11dhtxb2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only.