GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

FDA Premarket Approval P940034 S015

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Change to qc specification for the release of the amplification reagent.

DeviceGEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
Generic NameSystem, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
ApplicantGEN-PROBE, INC.
Date Received2004-01-22
Decision Date2004-02-10
PMAP940034
SupplementS015
Product CodeMWA 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Expedited ReviewNo
Combination Product No
Applicant Address GEN-PROBE, INC. 10210 Genetic Center Dr. san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P940034Original Filing
S019 2012-11-07 30-day Notice
S018 2010-03-31 30-day Notice
S017 2006-07-27 135 Review Track For 30-day Notice
S016 2004-09-21 30-day Notice
S015 2004-01-22 30-day Notice
S014
S013 2001-12-18 Special (immediate Track)
S012 2001-03-02 Normal 180 Day Track
S011 2000-10-25 Real-time Process
S010 1999-05-12 30-day Notice
S009 1998-10-19 Special (immediate Track)
S008 1998-09-04 Panel Track
S007 1998-08-17 Normal 180 Day Track
S006 1997-09-15 Normal 180 Day Track
S005 1997-07-02 Normal 180 Day Track
S004 1997-01-24 Normal 180 Day Track
S003 1996-06-17 Normal 180 Day Track
S002 1996-05-22 Special (immediate Track)
S001 1996-02-23 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15420045500303 P940034 019
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