• 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 test, factor ii g20210a mutations, genomic dna pcr
Definition In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Product CodeNPR
Regulation Number 864.7280
Device Class 2


Premarket Reviews
ManufacturerDecision
CEPHEID®
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1
Valvular Stenosis 1 1
Stenosis 1 1

-
-