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 enzyme linked immunosorbent assay, herpes simplex virus, hsv-2
Product CodeMYF
Regulation Number 866.3305
Device Class 2


Premarket Reviews
ManufacturerDecision
QUEST INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2023 252 252
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 190 190
Incorrect, Inadequate or Imprecise Result or Readings 60 60
False Negative Result 1 1
Device Remains Activated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 150 150
Insufficient Information 104 104
Viral Infection 1 1
Anxiety 1 1
Depression 1 1
Sleep Dysfunction 1 1
Decreased Appetite 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diasorin Inc. II Jan-25-2024
2 Siemens Healthcare Diagnostics, Inc II Mar-18-2021
-
-