PMA P100027S041

Device: INFORM HER2 Dual ISH DNA Probe Cocktail
Applicant: Ventana Medical Systems, Inc.
PMA number: P100027
Supplement: S041
Product code: NYQ
Decision date: 2024-01-26
Classification: Pathology
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Approval order statement: approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).

Current openFDA PMA Record#

Device: INFORM HER2 Dual ISH DNA Probe Cocktail
Applicant: Ventana Medical Systems, Inc.
PMA number: P100027
Supplement: S041
Product code: NYQ
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
Decision date: 2024-01-26
Decision code: APPR
Date received: 2023-10-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).