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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 NumberS007
Date Received11/22/2019
Decision Date12/18/2019
Product Code
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 
Moving (i) dry goods commodities, (ii) unlabeled product storage, (iii) label printing and (iv) kit storage within malvern, pa facilities.
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