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Sirolimus Test System

Sirolimus Test System is a medical device type in the Clinical Toxicology 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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Sirolimus Test System
Clinical Toxicology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NRP

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Class 2

21 CFR 862.3840

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Clinical Toxicology

Device Characteristics

No

No

No

Eligible

Definition

Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.