Product code SBL

Device name

Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

Medical specialty

Hematology

Device class

3

Regulation number

864.1860

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset