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Chromotitre E.I.A. Rubella IgG

by Ismunit Istituto Immunologico Intaliano

510(k) K872071

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872071 Date24 Aug 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
LFX
Device Class
Class II
Regulation
21 CFR Part 866.3510
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Chromotitre E.I.A. Rubella IgG is an Enzyme-Linked Immunosorbent Assay (ELISA) device designed for the qualitative detection of IgG antibodies to rubella virus in human serum or plasma. It functions as an immunodiagnostic test to aid in the serological diagnosis of rubella infection, including congenital rubella syndrome screening.

This device is intended for in vitro use in clinical microbiology laboratories and has been cleared under FDA 510(k) K872071 as a Microbiology Device under regulation 21 CFR 866.3510. Supplied as a single-use diagnostic kit, it requires no special storage conditions beyond refrigeration and is classified as Class II under FDA guidelines. The product code LFX identifies its regulatory submission.

Other devices from Ismunit Istituto Immunologico Intaliano

Questions

AI-generated answers, 19 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 Chromotitre E.I.A. Rubella IgG used for in a clinical setting?

    The Chromotitre E.I.A. Rubella IgG is an ELISA-based diagnostic test designed to qualitatively detect IgG antibodies against the rubella virus in human serum or plasma. It aids clinicians in confirming past rubella infection or assessing immunity, including screening for congenital rubella syndrome. The test is intended exclusively for in vitro use in clinical microbiology laboratories.

  • Is this device single-use, or can it be reused after sterilization?

    The Chromotitre E.I.A. Rubella IgG is supplied as a single-use diagnostic kit. Since it is intended for qualitative detection of IgG antibodies, reuse is not recommended or supported by the manufacturer, as it could compromise accuracy and sterility.

  • What storage conditions are required for this device?

    The Chromotitre E.I.A. Rubella IgG does not require special storage conditions beyond standard refrigeration. This ensures stability while maintaining the integrity of the test components for accurate results.

  • What regulatory pathway was followed for FDA clearance of this device?

    The Chromotitre E.I.A. Rubella IgG was cleared under the FDA’s 510(k) pathway (K872071) as a Microbiology Device under regulation 21 CFR 866.3510. The submission was reviewed by the Microbiology (MI) Advisory Committee and classified as substantially equivalent (SESE) to a predicate device. The product code assigned is LFX.

  • Can this test be performed on both serum and plasma samples?

    Yes, the Chromotitre E.I.A. Rubella IgG is explicitly designed for use with both human serum and plasma samples. This flexibility allows laboratories to adapt the test to the sample type most readily available for patient testing.