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. |
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Trade Name | MESOMARK |
Classification Name | cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma |
Generic Name | cancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesothelioma |
Applicant |
Fujirebio Diagnostics, Inc. |
201 great valley pkwy. |
malvern, PA 19355-1307 |
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HDE Number | H060004 |
Supplement Number | S007 |
Date Received | 11/22/2019 |
Decision Date | 12/18/2019 |
Product Code | |
Advisory Committee |
Immunology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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