Theratest EL-B2GP1 (IgM, IgG, IgA) and EL-B2GP1SCR
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K972790 FDA 510(k)
- FDA Product Code
- MSV 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 Theratest EL-B2GP1 (IgM, IgG, IgA) and EL-B2GP1SCR is an in vitro diagnostic test system. It is designed to measure the levels of IgM, IgG, and IgA antibodies directed against Beta 2 Glycoprotein 1 in human serum samples.
This device is intended for use in clinical laboratory settings. It is regulated under FDA 510(k) clearance K972790 and is classified as a Class 2 medical device under regulation number 866.5660.
Frequently asked questions
What is the primary purpose of the Theratest EL-B2GP1 system?
This device is an in vitro diagnostic test system intended for use in clinical laboratory settings to measure the levels of IgM, IgG, and IgA antibodies directed against Beta 2 Glycoprotein 1 in human serum samples.
What is the regulatory status of this diagnostic test?
The Theratest EL-B2GP1 is a Class 2 medical device that has received FDA 510(k) clearance under the number K972790, falling under regulation number 866.5660.
In what environment should this test system be utilized?
The system is specifically designed for use within clinical laboratory settings, ensuring that the measurement of antibodies against Beta 2 Glycoprotein 1 is performed in a controlled, professional environment.
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: The Theratest El-b2gp1 (Igm, Igg, Iga) and El-b2gp1scr, PDF K972790 - the Theratest El-b2gp1 (Igm, Igg, Iga) and El-b2gp1scr, Theratest-Laboratories FDA Filings - FDA.report, TheraTest Laboratories EL-B2GP1 (IgM, IgG, IgA) (8116)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972790 | Class II | Active |
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Manufacturer
- Manufacturer
- Theratest Laboratories, Inc.
Sources (1)
- FDA 510(k) K972790 24 fields · synced Sep 22, 2026