Hevylite Human IgA Kappa Kit for Siemens BNII, Hevylite Human IgA Lambda Kit for Siemens BNII

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

Full name

Hevylite Human Iga Kappa Kit for Use on Siemens Bnii, Hevylite Human Iga Lambda Kit for Use on Siemens Bnii

510(k) Number

K140105 ↗

FDA Product Code

OPX

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Alpha-1-Antitrypsin Immunological Nl Test Kit

  Class II

  FDA 510(k) K913666 Active Cleared 9 Dec 1991

• Anti-Tpo Eia Diagnostic Test Kit

  Class II

  FDA 510(k) K984163 Active Cleared 2 Feb 1999

• Ena Screening Cie Kit for Diagnostic Use

  Class II

  FDA 510(k) K924262 Active Cleared 29 Dec 1992

• Iga Minineph Antiserum

  Class II

  FDA 510(k) K981786 Active Cleared 24 Nov 1999

• Anticardiolipin Iga Screen Eia Diagnostic Test Kit

  Class II

  FDA 510(k) K983696 Active Cleared 5 Feb 1999

• Human Protein S Rid Test Kit

  Class II

  FDA 510(k) K951640 Active Cleared 21 Apr 1997

See all devices from The Binding Site, Ltd. →

• What conditions can the Hevylite Human IgA Kappa/Lambda Kit help diagnose or monitor?

  This kit quantifies free light chains (kappa and lambda) combined with IgA heavy chains in human serum, aiding in the diagnosis and monitoring of conditions like IgA multiple myeloma. Elevated or abnormal levels of these chains can indicate plasma cell disorders, making it useful for tracking disease progression or response to treatment.

• How are the Hevylite Human IgA Kappa/Lambda Kits supplied, and are they reusable?

  The kits are supplied as single-use reagents designed exclusively for laboratory in vitro diagnostic use. They are not intended for reuse, as single-use assays ensure accuracy, consistency, and compliance with regulatory standards for diagnostic testing.

• What nephelometer is required to use these kits, and are there compatibility concerns?

  These kits are specifically designed for use on the Siemens BNII nephelometer. While they are engineered to work seamlessly with this system, compatibility should always be verified by the laboratory prior to use, particularly if software or firmware updates have been applied.

• How should the Hevylite Human IgA Kappa/Lambda Kits be stored?

  Storage follows standard in vitro diagnostic protocols. The kits should be stored in a clean, dry environment at room temperature (15–30°C) away from direct sunlight and extreme humidity. Always refer to the included instructions for storage details and expiration dates to maintain assay integrity.

• Are there any special handling requirements for these kits, such as sterility or contamination risks?

  The kits are sterile and intended for single-use in controlled laboratory settings. Proper aseptic techniques should be used during handling to prevent contamination, as with all in vitro diagnostic reagents. Avoid exposure to extreme temperatures or physical stress, which could compromise sterility or performance.