Rickettsia Real-time PCR Assay by Centers for Disease Control and Prevention (CDC) | FDA 510(k) Summary

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K Number

Validate with FDA (Live)

Device Name

Rickettsia Real-time PCR Assay

Manufacturer

Centers for Disease Control and Prevention (CDC)

Date Cleared

2017-06-29

(91 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

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Predicate For

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Intended Use

Device Description

AI/ML Overview

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Regulation Number and Section

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