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 quantitative hepatitis b surface antigen
Definition A quantitative hepatitis B virus (HBV) surface antigen (HBsAg) test is an in vitro diagnostic device intended for prescription use for the quantitative determination of HBsAg in human serum, plasma, or other matrices specimens from individuals with HBV infection as an aid in the management of HBV-infected individuals including identifying patients who may benefit from treatment with appropriate antiviral therapies in accordance with the approved therapeutic product labeling.
Product CodeSJM
Regulation Number 866.3177
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS
  GRANTED 1

-
-