PMA P100027S029

Device

INFORM HER2 Dual ISH DNA Probe Cocktail

Applicant

Ventana Medical Systems, Inc.

PMA number

P100027

Supplement

S029

Product code

NYQ

Decision date

2018-09-13

Classification

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer

Generic name

Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

Approval order statement

Approval for implementing a BenchMark Scanners software supplement for Ventana Systems Software (VSS) 12.3 on the BenchMark ULTRA Instrument.

Summary

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