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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.
 
DeviceGEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
Classification Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Generic Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Regulation Number866.3372
Applicant
GEN-PROBE, INC.
10210 genetic center dr.
san diego, CA 92121
PMA NumberP940034
Supplement NumberS002
Date Received05/22/1996
Decision Date06/05/1996
Product Code
MWA[ Registered Establishments with MWA ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the package insert to include more details on adequate vortexing.
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