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

Premarket Approval (PMA)
  • 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 Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceQUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM
Generic NameTEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
ApplicantQIAGEN
19300 Germantown Road
Germantown, MD 20874
PMA NumberP010033
Supplement NumberS004
Date Received02/28/2003
Decision Date08/07/2003
Product Code NCD 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE USE OF THE QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM FOR USE WITH THE QUANTIFERON-TB TEST. THE DEVICE ACCESSORY WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM AND IS INDICATED AS A STAND ALONE PROGRAM FOR ANALYSIS OF RAW EIA DATA AND CALCULATION OF QUANTIFERON-TB ASSAY RESULTS.
-
-