FDA 510(k)

miDiagnostics HSV-1&2 CSFテスト

K番号: K250050 · 2025-09-30

決定日2025-09-30

製品コードPGH

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

miDiagnostics HSV-1&2 CSF Test is the device name listed in this FDA 510(k) record. The listed applicant is Midiagnostics NV. It received FDA 510(k) clearance on 2025-09-30 under 510(k) number K250050. The device is classified under product code PGH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the miDiagnostics HSV-1&2 CSF Test?

miDiagnostics HSV-1&2 CSF Test is a medical device that received FDA 510(k) clearance on 2025-09-30. The listed applicant is Midiagnostics NV. The 510(k) number is K250050.

When did miDiagnostics HSV-1&2 CSF Test receive FDA 510(k) clearance?

miDiagnostics HSV-1&2 CSF Test received FDA 510(k) clearance on 2025-09-30, under 510(k) number K250050.

Who is the listed applicant for miDiagnostics HSV-1&2 CSF Test?

The FDA 510(k) record lists Midiagnostics NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for miDiagnostics HSV-1&2 CSF Test?

The FDA product code for miDiagnostics HSV-1&2 CSF Test is PGH.

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医療機器の概要

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