FDA 510(k) Search

K Number

Device Name

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

Manufacturer

Centers for Disease Control and Prevention

Date Cleared

2025-07-11

Product Code

OZE

Regulation Number

866.3980

Intended Use

PDF not available yet

Device Description

PDF not available yet

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

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Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

AI/ML (Artificial Intelligence / Machine Learning)

null

Therapeutic

null

Diagnostic

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SaMD (Software as a Medical Device)

null

IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Summary

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View FDA Record ↗