|
Device | GEN-PROBE 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 | S013 |
Date Received | 12/18/2001 |
Decision Date | 01/25/2002 |
Reclassified Date
|
06/23/2014 |
Product Code |
MWA |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE RELATIVE LIGHT UNITS (RLU) SPECIFICATION FOR THE 0.2-0.3 MM WASHED GLASS BEADS (PART NO. 101321) AND FILLED LYSING TUBES (PART NO. 102606). |