染色原位杂交，核酸扩增，Her2/Neu基因，乳腺癌
PMA编号：P190031 · 2026-08-25
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器械摘要
常见问题
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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