• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device immunohistochemistry assay, antibody, ki-67
Definition The Ki-67 antibody is a qualitative immunohistochemical antibody intended to identify Ki-67 protein expression in human clinical tissue specimens. The KI-67 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Product CodeQQT
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
0 0 1 0 0 1

-
-