Antiserum to Human Kappa

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K822666 ↗

FDA Product Code

DFH

Device Class

Class II

Regulation

21 CFR Part 866.5550

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Ritc-Anti Human Iga, Igg, Kappa, Lambda

  Class II

  FDA 510(k) K823121 Active Cleared 17 Nov 1982

• Anti-Toxoplasma Gondii Kit

  Class II

  FDA 510(k) K842664 Active Cleared 28 Aug 1984

• Fitc Antisera to Human C3

  Class II

  FDA 510(k) K822679 Active Cleared 17 Nov 1982

• Fitc Antisera to Human Igg

  Class II

  FDA 510(k) K822676 Active Cleared 17 Nov 1982

• Antiserum to Human Gobulin

  Class II

  FDA 510(k) K822671 Active Cleared 17 Nov 1982

• Anti-Cytomegalovirus Kit

  Class II

  FDA 510(k) K842661 Active Cleared 6 Dec 1985

See all devices from Amico Lab, Inc. →

• What is the Antiserum to Human Kappa used for in laboratory settings?

  The Antiserum to Human Kappa is designed for immunology applications, specifically to detect and analyze human kappa light chains in serological testing and research. It serves as a diagnostic tool to identify and quantify kappa chains in clinical or research laboratory environments, aiding in the assessment of immune responses or antibody production.

• How is the Antiserum to Human Kappa supplied, and is it reusable?

  The product is supplied as a liquid formulation intended exclusively for laboratory use. It is classified for single-use only, meaning each vial or container should be discarded after one use to maintain sterility and accuracy. Reuse is not recommended or supported by the manufacturer.

• What storage conditions are required for the Antiserum to Human Kappa?

  While the exact storage conditions are not detailed in the provided data, antiserums of this type typically require controlled environments to preserve stability and efficacy. Generally, they should be stored refrigerated (between 2°C and 8°C) and protected from light. Always refer to the product labeling or manufacturer’s instructions for precise storage guidelines.

• Is the Antiserum to Human Kappa sterile, and how is it regulated?

  As a biological product intended for laboratory diagnostics, the Antiserum to Human Kappa is regulated under FDA 510(k) clearance (K822666) and falls under device classification DFH with regulation number 866.5550. While the data does not explicitly state sterility, antiserums of this nature are typically manufactured under sterile conditions to ensure safety for diagnostic use. The clearance indicates it is deemed Substantially Equivalent (SESE) to a predicate device.

• Does this product require third-party review or validation?

  No third-party review was conducted for this product, as indicated by the third_party_flag: N in the regulatory records. The FDA clearance process for this antiserum was completed through a traditional 510(k) pathway, reviewed by the Immunology (IM) advisory committee, without additional external validation.