FDA 510(k)

ノン-バリオラオルソポクスウイルスレアルタイムPCR プライマーおよびプローブセット

K番号: K181205 · 2018-09-20

申請者Centers for Disease Control and Prevention

決定日2018-09-20

製品コードPBK

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- MI --- URLや識別子などは原文のままです。

決定大幅同等

医療機器の概要

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2018-09-20 under 510(k) number K181205. The device is classified under product code PBK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is a medical device that received FDA 510(k) clearance on 2018-09-20. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K181205.

When did Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set receive FDA 510(k) clearance?

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set received FDA 510(k) clearance on 2018-09-20, under 510(k) number K181205.

Who is the listed applicant for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

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

What is the FDA product code for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set?

The FDA product code for Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is PBK.

申請者としてCenters for Disease Control and Preventionを記載するその他の記録

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