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 autoantibodies, skin (bullous pemphigoid 180 and bullous pemphigoid 230
Regulation Description Multiple autoantibodies immunological test system.
Definition The device is intended as an aid in the diagnosis of bullous pemphigoid.
Product CodeOEG
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
EUROIMMUN US, INC.
  SUBSTANTIALLY EQUIVALENT 1

-
-