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Rubella Microassay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K864602

by Diamedix Corp.

Identifiers

510(k) Number
K864602 FDA 510(k)
FDA Product Code
LFX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3510 FDA 510(k)
Regulation Number
866.3510 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Rubella Microassay is an Enzyme Linked Immunoabsorbent Assay (ELISA) designed for the detection of rubella antibodies. This laboratory test is used to identify immune responses to the rubella virus, aiding in the diagnosis of current or past infections. The assay operates based on immunoabsorbent principles to detect specific antibodies in patient samples.

The device is supplied as a Class II medical device under product code LFX with special controls. It is manufactured by Diamedix Corp. and received FDA 510(k) clearance on April 14, 1987. The device is intended for laboratory use and requires appropriate storage conditions as specified by the manufacturer. No information regarding sterility, single-use status, or MRI safety is provided in the available data.

Frequently asked questions

What is the Rubella Microassay used for?

The Rubella Microassay is an Enzyme Linked Immunoabsorbent Assay (ELISA) designed for the detection of rubella antibodies in patient samples. It helps identify immune responses to the rubella virus, aiding in the diagnosis of current or past rubella infections.

How is the Rubella Microassay supplied and what are its storage requirements?

The device is supplied as a Class II medical device under product code LFX with special controls. It requires appropriate storage conditions as specified by the manufacturer, though specific storage details are not provided in the available data.

What is the regulatory status of the Rubella Microassay?

The Rubella Microassay is manufactured by Diamedix Corp. and received FDA 510(k) clearance on April 14, 1987. It is classified as a Class II medical device under product code LFX with special controls.

Is the Rubella Microassay single-use or reusable?

The available data does not specify whether the Rubella Microassay is designed for single-use or reuse. No information regarding sterility or single-use status is provided in the device data.

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: K864602 - RUBELLA MICROASSAY | FDA 510 (k) | Diamedix Corp., Rubella Microassay 510 (k) FDA Premarket Notification K864602 DIAMEDIX ..., RUBELLA IGM MICROASSAY (K883778) — FDA 510 (k) | Innolitics, Diamedix Corp. · DeviceClearance, Diamedix Corp. — FDA 510 (k) clearances & recalls · 510k Monitor

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diamedix Corp.

Sources (1)

  • FDA 510(k) K864602 24 fields · synced Sep 26, 2026