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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 GOLD
Classification Nametest, immunity, cell mediated, mycobacterium tuberculosis
Generic Nametest, immunity, cell mediated, mycobacterium tuberculosis
Applicant
QIAGEN
19300 germantown road
germantown, MD 20874
PMA NumberP010033
Supplement NumberS006
Date Received12/04/2003
Decision Date12/02/2004
Product Code
NCD[ Registered Establishments with NCD ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE USE OF SYNTHETIC PEPTIDE ANTIGENS ESAT-6 AND CFP-10 AND REMOVAL OF THE TUBERCULIN PPD AND M. AVIUM PPD ANTIGENS USED IN THE QUANTIFERON - TB. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUANTIFERON - TB GOLD AND IS INDICATED FOR USE AS AN IN VITRO DIAGNOSTIC TEST USING PEPTIDE COCKTAILS SIMULATING ESAT-6 AND CFP-10 PROTEINS TO STIMULATE CELLS IN HEPARINIZED WHOLE BLOOD. DETECTION OF INTERFERON-Y BY ELISA IS USED TO IDENTIFY IN VITRO RESPONSES TO ESAT-6 AND CFP-10 THAT ARE ASSOCIATED WITH MYCOBACTERIUM TUBERCULOSIS INFECTION. THE DEVICE APPROVAL IS FOR USE OF AN 8-POINT CALIBRATION CURVE WITH MANUAL CALCULATIONS.
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