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FDA 510(k)

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

K-Number: K161556 · 2016-06-30

ApplicantCenters For Disease Control and Prevention (CDC)
Decision Date2016-06-30
Product CodeOZE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit is a medical device manufactured by Centers For Disease Control and Prevention (CDC). It received FDA 510(k) clearance on 2016-06-30 under approval number K161556. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit?

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit is a medical device that received FDA 510(k) clearance on 2016-06-30. It is manufactured by Centers For Disease Control and Prevention (CDC). The 510(k) number is K161556.

When was CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit approved by the FDA?

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit received FDA 510(k) clearance on 2016-06-30, under approval number K161556.

What company makes CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit?

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit is manufactured by Centers For Disease Control and Prevention (CDC).

What is the FDA product code for CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit?

The FDA product code for CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit is OZE.

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Related PubMed Literature

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Other Devices by Centers For Disease Control and Prevention (CDC)

K170940Rickettsia Real-time PCR Assay DEN160016Variola virus Real-Time PCR Assay K181736CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,

Related Devices (Code: OZE)

K172091CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping KitCenters for Disease Control and Prevention K181736CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,Centers For Disease Control and Prevention (CDC) K171641Accula Flu A/Flu B TestMesa Biotech, Inc. K182513FluChip-8G Influenza A+B AssayIndevr, Inc. K190302CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping KitCenters for Disease Control and Prevention K190204ID NOW Influenza A & B 2Alere Scarborough, Inc.

Official Source

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