Rubalex, Modification

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K912391 ↗

FDA Product Code

LQN

Device Class

Class II

Regulation

21 CFR Part 866.3510

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Rubalex

  Class II

  FDA 510(k) K852788 Active Cleared 12 Mar 1986

• Microalbuminuria Assay

  Class II

  FDA 510(k) K862671 Active Cleared 18 Sep 1986

• Oricult-N Culture-Paddle

  Class I

  FDA 510(k) K872058 Active Cleared 10 Jun 1987

• Immunochemical Assay Apolipoprotein B

  Class I

  FDA 510(k) K861882 Active Cleared 29 Oct 1986

• Chlamyset Antibody Eia

  Class I

  FDA 510(k) K864457 Active Cleared 11 Sep 1987

• Mamex Dc Mag MG12

  Class II

  FDA 510(k) K881506 Active Cleared 10 Jun 1988

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• What is the Rubalex Modification device used for?

  The Rubalex Modification is a latex agglutination assay designed to detect rubella antibodies in microbiology testing. It utilizes latex particles coated with rubella antigen to produce visible agglutination when specific antibodies are present.

• How is the Rubalex Modification device supplied?

  The device is supplied as a latex agglutination assay kit containing latex particles coated with rubella antigen. The specific packaging and components would be detailed in the product instructions provided by Orion Corp.

• What is the regulatory status of the Rubalex Modification device?

  The Rubalex Modification device was cleared by the FDA through a traditional 510(k) pathway (K912391) as a Class II device with product code LQN and regulation number 866.3510. It received clearance on May 4, 1992.

• Is the Rubalex Modification device single-use or reusable?

  The device description does not specify whether it is single-use or reusable. This information would be detailed in the product instructions provided by Orion Corp., which would outline proper handling and disposal procedures.