Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameQUANTIFERON - TB GOLD IN-TUBE
Classification Nametest, immunity, cell mediated, mycobacterium tuberculosis
ApplicantCELLESTIS INC
PMA NumberP010033
Supplement NumberS015
Date Received06/24/2009
Decision Date01/25/2010
Product Code
NCD[ Registered Establishments with NCD ]
Advisory Committee Microbiology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to allow the use of dry peptides to be formulated at cellestis and shipped to the contract manufacturer for the manufacture of tb antigen blood collection tubes.
-
-