510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SBLClass III

Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

21 CFR 864.1860 / Hematology
FDA source (opens on fda.gov)

SBL is the FDA product code for Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4, a class III device type, regulated under 21 CFR 864.1860. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SBL
Device name
Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4
FDA 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.
Regulation
21 CFR 864.1860
Device class
Class III
Review panel
Hematology
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code