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Randox Complement C3

FDA 510(k)

Class II (US FDA 510(k))

510(k) K000469

by Randox Laboratories, Ltd.

Identifiers

510(k) Number
K000469 FDA 510(k)
FDA Product Code
CZW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5240 FDA 510(k)
Regulation Number
866.5240 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Randox Complement C3 is a reagent used for the quantitative in vitro determination of complement C3 concentration in serum. It is a complex biological system that works in conjunction with antibodies and other factors to protect the body from invasion by pathogens. The assay allows for the diagnosis and monitoring of autoimmune disorders associated with abnormal levels of complement C3. Complement C3 is a component of the complement system, which acts on biological membranes and may cause cell death when activated.

The Randox Complement C3 assay is supplied for use in immunology applications. It is intended for use in the diagnosis and monitoring of conditions such as lupus and rheumatoid arthritis, and may also be indicative of cancer or ulcerative conditions. The device has been cleared under FDA 510(k) number K000469, with a regulation number of 866.5240, and is classified as a class 2 device.

Frequently asked questions

What is the Randox Complement C3 reagent used for?

The Randox Complement C3 reagent is used for the quantitative in vitro determination of complement C3 concentration in serum, which helps in diagnosing and monitoring autoimmune disorders such as lupus and rheumatoid arthritis.

Is the Randox Complement C3 reagent supplied sterile?

The description does not explicitly state that the Randox Complement C3 reagent is supplied sterile, so its sterility should be confirmed with the manufacturer.

What is the regulatory status of the Randox Complement C3 reagent?

The Randox Complement C3 reagent has been cleared under FDA 510(k) number K000469, and is classified as a class 2 device with regulation number 866.5240.

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: Randox Featured Reagent Complement C3 - Randox Laboratories, Complement C3 | Biochemistry | Reagent | Randox Laboratories, RANDOX COMPLEMENT C3 (K000469) - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA 510(k) K000469 24 fields · synced Sep 26, 2026