|
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 |
|
HDE Number | H060004 |
Date Received | 09/13/2006 |
Decision Date | 01/24/2007 |
Product Code | |
Docket Number | 07M0038 |
Advisory Committee |
Immunology |
Supplement Type | hde original |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the mesomarktm assay. This device is indicated for: the fujirebio diagnostics, inc. (fdi) mesomarktm is an enzyme linked immunosorbent assay (elisa) for the quantitative measurement of soluble mesothelin related peptides (smrp) in human serum. Measurement of smrp may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. Mesomarktm values must be interpreted in conjunction with all other available clinical laboratory data. |
Approval Order | Approval Order |
Summary | Summary of Safety And Probable Benefit |
Labeling | Labeling
|
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 |