Pure Global AI
FDA product code SBL

Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

HematologyClass 321 CFR 864.1860
Verified
US regulatory classifications
US Product Code (FDA)
SBL
View Product Code Classification
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR 864.1860
View CFR Regulation
Medical specialty
Hematology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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01IHC assay02Melanoma assay03Antibody test04Cancer diagnostic05Tissue assay06Lab assay07Pathology assay08Immunohistochemistry09Diagnostic test10Antigen test
About this record

Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4 is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.