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 elisa, antibody, west nile virus
Definition The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.
Product CodeNOP
Regulation Number 866.3940
Device Class 2


Premarket Reviews
ManufacturerDecision
EUROIMMUN US, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Output above Specifications 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Calibration Problem 1 1
Improper Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Focus Diagnostics Inc III Oct-31-2012
2 Inverness Medical II Feb-14-2012
-
-