Identifiers
- 510(k) Number
- K130528 FDA 510(k)
- FDA Product Code
- MID FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5660 FDA 510(k)
- Regulation Number
- 866.5660 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BioPlex 2200 APLS IgM is an immunological test system designed to detect IgM class antiphospholipid antibodies, including anti-cardiolipin and anti-β2-glycoprotein I, in serum or plasma samples. It is classified as a System, Test, Anticardiolipin Immunological device and is used for diagnostic purposes in immunology, specifically for assessing antiphospholipid syndrome markers.
This device is supplied as a reagent, calibrator, and control set for up to 100 samples and is intended for in vitro diagnostic use in clinical laboratories. It is regulated under FDA 510(k) clearance (K130528) and falls under Class II medical devices (21 CFR 866.5660). The system operates on the Bio-Rad Laboratories’ Luminex xMAP® technology platform, requiring no additional sterilization beyond standard laboratory practices for reagent kits.
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: BioPlex 2200 APLS IgM - Bio-Rad, BioPlex 2200 APLS IgG, IgM and IgA - Bio-Rad, PDF BioPlex® 2200 Antiphospholipid Syndrome (APLS) IgM 510(k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130528 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA 510(k) K130528 24 fields · synced Sep 19, 2026