FDA PMA

キット、RNA検出、人間パピローマウスウイルス

PMA番号：P120007 · 2026-02-03

申請者Gen-Probe Incorporated

決定日2026-02-03

PMA番号P120007

製品コードOYB

デバイスクラスクラス3

診療科U

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。

医療機器の概要

Kit, rna detection, human papillomavirus is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe Incorporated. It received FDA 510(k) clearance on 2026-02-03. The device is classified under product code OYB. It was reviewed by the MI advisory panel.

よくある質問

What is the Kit, rna detection, human papillomavirus?

Kit, rna detection, human papillomavirus is a medical device that received FDA 510(k) clearance on 2026-02-03. The listed applicant is Gen-Probe Incorporated.

When did Kit, rna detection, human papillomavirus receive FDA 510(k) clearance?

The clearance date for Kit, rna detection, human papillomavirus can be found in the official FDA records.

Who is the listed applicant for Kit, rna detection, human papillomavirus?

The FDA 510(k) record lists Gen-Probe Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kit, rna detection, human papillomavirus?

The FDA product code for Kit, rna detection, human papillomavirus is OYB.

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医療機器の概要

よくある質問

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