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 system, test, genotypic detection, resistant markers, staphylococcus colonies
Product CodeMYI
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANDX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALERE SCARBOROUGH, INC
  SUBSTANTIALLY EQUIVALENT 2
BINAX, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 2 2
Improper or Incorrect Procedure or Method 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2

-
-