Amplicor (TM) Mycobacterium Tuberculosis Test

FDA premarket approval P940040 · System, nucleic acid amplification, mycobacterium tuberculosis complex

PMA numberP940040

Approval

Applicant
Roche Molecular Systems, Inc.
Received
December 22, 1994
Decision date
November 26, 1996 (APWD)
Supplements
9, latest November 25, 2008
Product code
MWA – System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

Official FDA PMA record

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.