Variola virus Real-Time PCR Assay by CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) | FDA 510(k) Summary

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K Number

Device Name

Variola virus Real-Time PCR Assay

Manufacturer

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

Date Cleared

2017-02-06

(298 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

AI/ML Overview

Summary

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Regulation Number and Section

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