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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 NumberS003
Date Received04/27/2011
Decision Date06/01/2011
Product Code
OAW
Advisory Committee Immunology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the following changes:). An additional statement is being added to the "warnings and precautions" section of the product insert for the kit. The updated product insert will not be used untilseptember 2011. From december 2010 to september 2011, a kit stuffer is produced to notify customers that the following statement will be added under the "warningsand precautions" section: discard mesomark coated plate strip if visible residue is detected on the underside of some microtiter wells. 2) an inspection process of coated plates is being instituted in the solid phase department. Each coated plate is 200% inspected (100% inspection by 2 operators)before being pouched. Any plate found to exhibit residue is rejected.
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