Tri-Level Ligand Control

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

510(k) Number

K864877 ↗

FDA Product Code

DHX

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Ciba Corning Magic(R) Lite Tu Immunoassay

  Class II

  FDA 510(k) K864132 Active Cleared 16 Dec 1986

• Gilford Uniqual Abnormal Control Serum/Unassayed

  Class I

  FDA 510(k) K860998 Active Cleared 3 Apr 1986

• Acs FRT4 Immunoassay

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  FDA 510(k) K961510 Active Cleared 17 Jun 1996

• Ciba Corning Certain Lyte

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  FDA 510(k) K894576 Active Cleared 30 Oct 1989

• Ciba Corning ACS;180 Dpd Assay

  Class I

  FDA 510(k) K963251 Active Cleared 15 Oct 1996

• Ciba Corning Magic Lite Chlamydia Immunoassay

  Class I

  FDA 510(k) K895122 Active Cleared 30 Oct 1989

See all devices from Ciba Corning Diagnostics Corp. →

• What is the Tri-Level Ligand Control used for?

  The Tri-Level Ligand Control is designed as a control for ligand-based assays, providing three distinct levels to support calibration and quality control in diagnostic testing, specifically for immunoassay systems in laboratory settings.

• How is the Tri-Level Ligand Control supplied and what is its regulatory status?

  Supplied by Ciba Corning Diagnostics Corp., the device received FDA 510(k) clearance (K864877) on May 21, 1987, under regulation number 866.6010, and is classified as a Class II device with special controls and product code DHX.

• Is the Tri-Level Ligand Control intended for single-use or reuse?

  The device data does not specify whether the Tri-Level Ligand Control is intended for single-use or reuse; it is described as a control for ligand-based assays used in laboratory settings as part of immunoassay systems, but no details on reusability are provided in the authorization or description.