Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 next generation sequencing oncology panel, somatic or germline variant detection system
Definition A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.
Product CodePQP
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
17 33 34 34 21 8

Recalls
Manufacturer Recall Class Date Posted
1 AGILENT TECHNOLOGIES INC./US III Apr-11-2023
2 CARIS LIFE SCIENCES II Sep-04-2025
3 Foundation Medicine, Inc. II Apr-23-2026
4 Foundation Medicine, Inc. II Apr-22-2026
5 Foundation Medicine, Inc. II Nov-21-2025
6 Foundation Medicine, Inc. II May-30-2025
7 Foundation Medicine, Inc. II May-30-2025
8 Foundation Medicine, Inc. II May-12-2025
-
-