SBL
- Product code
- SBL
- Device name
- Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4
- Device class
- Class 3
- 21 CFR
- 21 CFR 864.1860
- Medical specialty
- Hematology
- Marketing pathway
- PMA
FDA classification definition
Melanoma-associated antigen A4 (MAGE-A4) antibody is a qualitative immunohistochemical antibody, intended for use in the detection of MAGE-A4 protein expression in human clinical tissue specimens. The MAGE A4 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.
Official FDA classification page: SBL
Classification and pathway per current FDA publications. Data from openFDA (CC0).