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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameMesomark
Classification Namecancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma
Generic Namecancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma
Applicant
Fujirebio Diagnostics, Inc.
201 great valley pkwy.
malvern, PA 19355-1307
HDE NumberH060004
Supplement NumberS004
Date Received05/25/2017
Decision Date06/19/2017
Product Code
OAW[ Registered Establishments with OAW ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the following changes: (1) new supplier for bsa, a raw material used in the manufacturing of the device, and (2) optimization of the mesomark 569-hrp in-process conjugate concentrate dilution scheme used during the manufacturing of the device.
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