ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163133 FDA 510(k)
- FDA Product Code
- DBM FDA 510(k)
- Models / Variants
- ImmuLisa Enhanced AMA IgG Antibody ELISA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5090 FDA 510(k)
- Regulation Number
- 866.5090 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ImmuLisa Enhanced AMA IgG Antibody ELISA and ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA are enzyme linked immunosorbent assays (ELISA) for the qualitative detection of anti-mitochondria antibodies (AMA) in human serum. These assays aid in the diagnosis of primary biliary cirrhosis (PBC) in conjunction with other laboratory tests and clinical findings. The device is classified as an Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control. The medical specialty description is Immunology.
The ImmuLisa Enhanced AMA IgG Antibody ELISA and ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA are supplied with a product code of DBM and a regulation number of 866.5090. The device has been cleared with a Traditional 510K clearance type and has an FDA 510K authorization. The manufacturer, Immco Diagnostics, Inc., is located in the US, with the device registered under several numbers, including 8043792 and 2026994.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG ..., ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG ..., Immulisa Enhanced Ama Igg Antibody Elisa; Immulisa Enhanced Ama Iga/igg ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163133 | Class II | Active |
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Manufacturer
- Manufacturer
- Immco Diagnostics, Inc.
Sources (1)
- FDA 510(k) K163133 24 fields · synced Sep 24, 2026