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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 NameGEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
Generic Nametarget amplification test for the direct detection of mycobacterium tuberculosis
ApplicantGEN-PROBE, INC.
PMA NumberP940034
Supplement NumberS006
Date Received09/15/1997
Decision Date10/30/1997
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacturing facility relocation to 10210 genetic center dr. , san diego, ca.
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