ALPHA-1-ANTITRYPSIN, Fitc, Antigen

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K840867 ↗

FDA Product Code

DEI

Device Class

Class II

Regulation

21 CFR Part 866.5130

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the Alpha-1-Antitrypsin FITC Antigen used for?

  This device functions as an immunological reagent, specifically serving as an antiserum or control in laboratory testing. It is designed to interact with human alpha-1-antitrypsin derived from serum or plasma.

• How is the antibody in this reagent produced?

  The antibody is a polyclonal reagent derived from goats that have been immunized with purified human alpha-1-antitrypsin. Following immunization, the antibody is isolated through affinity chromatography to ensure purity.

• What is the regulatory status of this reagent?

  This product is classified as a class 2 medical device under regulation number 866.5130. It has received FDA 510(k) clearance, confirming it is substantially equivalent to legally marketed predicate devices.

• How is the concentration of the reagent determined?

  The concentration of the Alpha-1-Antitrypsin FITC Antigen is determined based on its specific extinction coefficient, ensuring that the reagent meets the necessary standards for use as a control or antiserum.