Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST |
Generic Name | System, nucleic acid amplification, mycobacterium tuberculosis complex |
Regulation Number | 866.3372 |
Applicant | Roche Molecular Systems, Inc. 4300 HACIENDA DR. PLEASANTON, CA 94588-0900 |
PMA Number | P940040 |
Date Received | 12/22/1994 |
Decision Date | 11/26/1996 |
Withdrawal Date
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09/06/2013 |
Product Code |
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 |
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