Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

SBL · Class III — High Risk (PMA approval required, life-sustaining) · Hematology · 21 CFR 864.1860

Classification

FDA Product Code: SBL
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: 21 CFR 864.1860
Review panel: PA
Medical specialty: Hematology
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown