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 vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system
Definition An in vitro diagnostic assay for use in genotyping vitamin k epoxide reductase complex subunit one (VKORC1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity.
Product CodeODV
Regulation Number 864.7750
Device Class 2

MDR Year MDR Reports MDR Events
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 2 2
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ossification 2 2
Dysphagia/ Odynophagia 2 2
Osteolysis 1 1
Sore Throat 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

-
-