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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameQUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM
Classification Nametest, immunity, cell mediated, mycobacterium tuberculosis
ApplicantCELLESTIS LIMITED
PMA NumberP010033
Supplement NumberS004
Date Received02/28/2003
Decision Date08/07/2003
Product Code
NCD[ Registered Establishments with NCD ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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.
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