顏色原位雜交，核酸放大，Her2/Neu 基因，乳癌
PMA 核准號：P190031 · 2026-08-25
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器材摘要
常見問題
What is the Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer?
Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Ventana Medical Systems, Inc..
When did Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer receive FDA 510(k) clearance?
The clearance date for Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer can be found in the official FDA records.
Who is the listed applicant for Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer?
The FDA 510(k) record lists Ventana Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer?
The FDA product code for Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer is NYQ.
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