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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Roche Molecular Systems, Inc.
4300 hacienda dr.
pleasanton, CA 94588-0900
PMA NumberP940040
Date Received12/22/1994
Decision Date11/26/1996
Withdrawal Date 09/06/2013
Product Code
MWA[ Registered Establishments with MWA ]
Docket Number 97M-0125
Notice Date 04/01/1997
Advisory Committee Microbiology
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the amplicor(r) mycobacterium tuberculosis(mtb) test. The device is a target amplified in vitro diagnostic test for the qualitative detection of m. Tuberculosis complex dna in concentrated sediments prepared from sputum (induced or expectorated), bronchial specimens including bronchoalveolar lavages or aspirates, or tracheal aspirates.
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010