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FDAMarket Authorization

[PMA Approved] HER2 Dual ISH DNA Probe Cocktail — Ventana Medical Systems, — P190031

Jul 28, 2020
Decision Date: 2020-07-28Published: 2020-07-28Captured: 2026-02-20Ventana Medical Systems, Inc.Device: HER2 Dual ISH DNA Probe CocktailProduct Code: NYQ

FDA approved PMA P190031 (decision: APPR). HER2 Dual ISH DNA Probe Cocktail by Ventana Medical Systems, Inc..

  • •Trade name: HER2 Dual ISH DNA Probe Cocktail
  • •Applicant: Ventana Medical Systems, Inc.
  • •Decision: APPR
  • •Product code: NYQ
Decision:APPR
Device Class:3
Advisory Committee:PA
Statement/Summary:Approval for the VENTANA HER2 Dual ISH DNA Probe Cocktail assay.
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HER2 Dual ISH DNA Probe Cocktail — Ventana Medical Systems, Inc. | TrueMedDevice