FITC Antisera to Human IgA

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

510(k) Number

K822675 ↗

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 primary use of the FITC Antisera to Human IgA in a clinical setting?

  This device is designed for identifying and quantifying human immunoglobulin A (IgA) in immunological assays. It works as a fluorescent marker, allowing samples to be visualized under ultraviolet light during serological testing, which helps in diagnosing conditions related to immunology.

• How is the FITC Antisera to Human IgA supplied, and is it intended for single-use or reuse?

  The product is supplied as a reagent for in vitro diagnostic use in laboratory settings. While the data does not explicitly state whether it is single-use or reusable, it is typically standard practice for fluorescent antisera to be single-use due to potential degradation of the fluorescent marker over repeated use.

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

  The FITC Antisera to Human IgA received FDA 510(k) clearance under the traditional review pathway, with a decision date of November 17, 1982. It was determined to be substantially equivalent to a predicate device, as indicated by the clearance type and decision description.

• Is there any information provided about the sterility of this product?

  The available data does not specify whether the FITC Antisera to Human IgA is sterile or not. If sterility is a critical requirement for your application, you should verify this directly with the manufacturer, Amico Lab, Inc.

• What medical specialty is primarily associated with the use of this device?

  The device is classified under the medical specialty of immunology, as indicated by the advisory committee (IM) and the product code (DFH). This aligns with its use in serological testing for immunoglobulin A.