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U.S. Department of Health and Human Services

Product Classification
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Device chromogranin a
Regulation Description Tumor-associated antigen immunological test system.
Definition In vitro test to measure Chromogranin A (CgA) as an aid in monitoring during the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors.
Physical State Immunofluorescent reagents, monoclonal antibody conjugated with cryptate, monoclonal antibody conjugated with Alexa Fluor 647
Technical Method Immunofluorescent assay
Target Area Venous blood serum, but other specimen types may be possible
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeQXS
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.6010
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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