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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 NumberS008
Date Received12/09/2020
Decision Date01/05/2021
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 
Relocating label application operations formesomark assay kits within the same building in order to address expanding production and inventory space needs.
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