Ki-67 IHC pharmDx

FDA premarket approval P210026 · decided 2021-10-12

Approval details

PMA number: P210026
Trade name: Ki-67 IHC pharmDx
Generic name: Immunohistochemistry assay, antibody, Ki-67
Applicant: Agilent Technologies, Inc.
Date received: 2021-06-30
Decision date: 2021-10-12
Days to decision: 104 days
Decision code: APPR
Product code: QQT
Advisory committee: Pathology
Expedited review: No
Location: Santa Clara, CA
Statement: Approval of Ki-67 IHC MIB-1 pharmDx (Dako Omnis)For In Vitro Diagnostic Use.Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is a qualitative immunohistochemical (IHC) assay using monoclonal mouse anti-Ki-67, Clone MIB-1, intended for use in the detection of Ki-67 protein in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue using the EnVision FLEX visualization system on Dako Omnis.Ki-67 protein expression in breast carcinoma is determined by using the Ki-67 pharmDx Score, which is the overal

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Record	Firm	Date
GenetiSure Dx Postnatal Assay (K163367)	Agilent Technologies, Inc.	2017-08-11
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HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A (K003819)	Agilent Technologies, Inc.	2001-05-02
AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 (K011093)	Agilent Technologies, Inc.	2001-05-01
M2376A DEVICELINK SYSTEM (K010453)	Agilent Technologies, Inc.	2001-03-02