SBL — Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4 Class III
FDA product code SBL covers "Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4", a Class III medical device regulated under 21 CFR 864.1860. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- SBL
- Device Class
- Class III
- Regulation Number
- 864.1860
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
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.