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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.
Classification Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Generic Namesystem, nucleic acid amplification, mycobacterium tuberculosis complex
Regulation Number866.3372
10210 genetic center dr.
san diego, CA 92121
PMA NumberP940034
Supplement NumberS001
Date Received02/23/1996
Decision Date04/23/1996
Product Code
MWA[ Registered Establishments with MWA ]
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: 1)a component (nalc) in a liquid reagent (enzyme dilution buffer) is moved to a lyophilized reagent (enzyme reagent), resulting in a stability shelf life of 1 year for the reagents and 1 year for the kit; 2) add an additional vendor of reverse transcriptase; and, 3) insignificant changes to the package insert.