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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.
 
DeviceGEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
Applicant
GEN-PROBE, INC.
10210 genetic center dr.
san diego, CA 92121
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/sterilizer/packager/supplier
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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