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Rubindex Direct System

by Ortho Diagnostics, Inc.

510(k) K781638

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781638 Date20 Dec 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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
GOK
Device Class
Class II
Regulation
21 CFR Part 866.3510
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Rubindex Direct System is an antisera device used for the detection of Rubella, including the use of hemagglutination inhibition (HAI) control. It functions as a diagnostic tool within the field of microbiology.

This device is regulated under FDA 510(k) clearance K781638. It is classified as a class 2 medical device under regulation number 866.3510.

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Questions

AI-generated answers, 27 Sep 2026

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

  • What is the primary function of the Rubindex Direct System?

    The Rubindex Direct System is a diagnostic tool designed for the detection of Rubella. It is specifically categorized as an antisera device and includes the use of hemagglutination inhibition (HAI) control to support its diagnostic function in microbiology.

  • How is this device regulated?

    The Rubindex Direct System is regulated under FDA 510(k) clearance number K781638. It is classified as a class 2 medical device under regulation number 866.3510, which pertains to antisera used for the detection of Rubella.

  • What is the regulatory classification of this device?

    This device is classified as a class 2 medical device. This classification is based on the regulation number 866.3510, which covers antisera, including HAI control, used for the detection of Rubella within the field of microbiology.