FDA PMA

면역조직학 검사, DNA 미스매치 보정(MMR) 단백질 검사

PMA 번호: P210001 · 2026-01-06

신청자Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)

결정일2026-01-06

PMA 번호P210001

제품 코드QNH

의료기기 등급등급 3

의학적 전문분야H

규정 번호21 CFR 8

자문 위원회PA

기기 요약

Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). It received FDA 510(k) clearance on 2026-01-06. The device is classified under product code QNH. It was reviewed by the PA advisory panel.

자주 묻는 질문

What is the Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay?

Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay is a medical device that received FDA 510(k) clearance on 2026-01-06. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics).

When did Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay can be found in the official FDA records.

Immunohistochemistry 검사, DNA mismatch repair (MMR) 단백질 검사의 등록된 신청자는 누구인가요?

The FDA 510(k) record lists Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) as the applicant. This does not by itself establish the device manufacturer.

FDA 제품 코드는 Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay에 대해 무엇인가요?

FDA 제품 코드는 Immunohistochemistry 검사, DNA mismatch repair (MMR) 단백질 검사에 대해 QNH입니다.

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