FDA product code SBL: Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4
SBL is the FDA product code for immunohistochemistry assay, antibody, melanoma-associated antigen a4. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. Devices under SBL reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4 |
| Device class | Class III |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | PMA |
Recalls for SBL devices
openFDA lists no recalls for product code SBL.
Frequently asked questions
What is FDA product code SBL?
SBL is the FDA product code for immunohistochemistry assay, antibody, melanoma-associated antigen a4. It is a Class III device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is SBL?
Class III, regulation 21 CFR 864.1860. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SBL
- Run a recall and safety report across every SBL manufacturer
- Watch product code SBL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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