FDA 510(k)

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,

Número K: K181736 · 2018-07-30

RequerenteCenters For Disease Control and Prevention (CDC)

Data da decisão2018-07-30

Código do produtoOZE

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, is the device name listed in this FDA 510(k) record. The listed applicant is Centers For Disease Control and Prevention (CDC). It received FDA 510(k) clearance on 2018-07-30 under 510(k) number K181736. The device is classified under product code OZE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,?

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, is a medical device that received FDA 510(k) clearance on 2018-07-30. The listed applicant is Centers For Disease Control and Prevention (CDC). The 510(k) number is K181736.

When did CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, receive FDA 510(k) clearance?

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, received FDA 510(k) clearance on 2018-07-30, under 510(k) number K181736.

Who is the listed applicant for CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,?

The FDA 510(k) record lists Centers For Disease Control and Prevention (CDC) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,?

The FDA product code for CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, is OZE.

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Dispositivos Relacionados (Código: OZE)

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