• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namemycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test
PMA NumberP070006
Supplement NumberS004
Date Received02/22/2010
Decision Date03/19/2010
Product Code
OJN[ Registered Establishments with OJN ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an extra approved supplier (us biological, inc. ) of phytohemagglutinin and of another supplier (thermo fisher scientific gmbh) of antigen peptides (panels a and b) for the t-spot®. Tb kits.