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Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples 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.

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Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QPO

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Class 2

21 CFR 866.2952

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Microbiology

Device Characteristics

No

No

No

Not Eligible

Definition

A device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples is a device that consists of a container and reagents intended to stabilize microbial nucleic acids for the subsequent assessment of the relative abundance of microbial nucleic acids (i.e., microbiome) in human specimens by an assay validated for use with the device. The device may also be indicated for sample collection. The device is not intended for preserving morphology or viability of microorganisms.