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Rubella Microassay

by Diamedix Corp.

510(k) K864602

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK864602 Date14 Apr 1987ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LFX
Device class
Class II
Regulation
21 CFR Part 866.3510
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella).

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