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Positive Blood Culture Identification And Ast Kit

Positive Blood Culture Identification And Ast Kit is a medical device type in the Microbiology 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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Positive Blood Culture Identification And Ast Kit
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PRH

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Class 2

21 CFR 866.1650

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Microbiology

Device Characteristics

No

No

No

Not Eligible

Definition

Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.