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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameCELLFREE(R) INTERLEUKIN-2 RECEPTOR* BEAD ASSAT KIT
Classification Nameassay, interleukin
ApplicantPIERCE BIOTECHNOLOGY, INC.
PMA NumberP880040
Supplement NumberS003
Date Received03/24/1995
Decision Date08/07/1996
Product Code
MAN
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in address of the manufacturing site and updates and revisions in standard operating procedures and manufacturing information.
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