Note: 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. |
|
Device | GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) |
Generic Name | System, nucleic acid amplification, mycobacterium tuberculosis complex |
Regulation Number | 866.3372 |
Applicant | GEN-PROBE, INC. 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121 |
PMA Number | P940034 |
Supplement Number | S001 |
Date Received | 02/23/1996 |
Decision Date | 04/23/1996 |
Reclassified Date
|
06/23/2014 |
Product Code |
MWA |
Advisory Committee |
Microbiology |
Supplement Type | Normal 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 |
|
|