FITC Antisera To Human Gobulin

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

510(k) Number

K822678 ↗

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 FITC Antisera To Human Gobulin used for?

  FITC Antisera To Human Gobulin is used as a secondary antibody in immunology laboratory assays for detecting human immunoglobulins. It is purified through pepsin digestion and immunoaffinity chromatography, with Fc fragments and whole IgG molecules removed.

• How is the FITC Antisera To Human Gobulin supplied?

  The device is supplied as a laboratory reagent. The description does not specify whether it is single-use or reusable, indicating it should be handled according to standard laboratory reagent protocols.

• What is the regulatory status of the FITC Antisera To Human Gobulin?

  The device is regulated under FDA 510(k) clearance with product code DFH, classified as Class II, and has the model number K822678. It received clearance on November 17, 1982.

• What are the specifications of the FITC Antisera To Human Gobulin?

  The device is described as substantially equivalent and is intended for immunology applications. It is manufactured by Amico Lab, Inc. and has been cleared for use in detecting human immunoglobulins in laboratory assays.