Antisera to Human ALPHA1-ANTITRYPSIN

No FDA recalls on record, checked 6 Oct 2026.

Full name

N Antisera to Human ALPHA1-Antitrypsin

510(k) Number

K053072 ↗

FDA Product Code

DEM

Device Class

Class II

Regulation

21 CFR Part 866.5130

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Dade Behring, Inc. →

• What is the primary use of the N Antiserum to Human Alpha1-Antitrypsin in a clinical setting?

  This antiserum is designed for the quantitative measurement of human alpha1-antitrypsin levels in serum or plasma samples. It functions as an antigen-specific antibody reagent within an immunonephelometry assay, enabling precise turbidimetric immunoassay results for laboratory diagnostics.

• Is this product sterile, and how should it be handled to maintain its integrity?

  The N Antiserum to Human Alpha1-Antitrypsin is not sterile and is intended for single-use per batch. To preserve assay accuracy, storage and handling must strictly follow the manufacturer’s guidelines, as outlined in 21 CFR 866.5130.

• Can this reagent be reused, or is it intended for single-use only?

  This product is explicitly designed for single-use per batch, meaning each batch should not be reused after opening or initial use. This aligns with regulatory standards to ensure consistent and reliable assay performance.

• What type of regulatory clearance does this device hold, and how was it classified?

  The N Antiserum to Human Alpha1-Antitrypsin holds a 510(k) clearance (K053072) under the FDA’s Traditional pathway, classified as substantially equivalent under the nomenclature for immunology reagents. It was reviewed by the Immunology (IM) Advisory Committee and falls under product code DEM.

• Where is this product manufactured, and how should it be stored?

  The product is manufactured by Dade Behring, Inc., based in Newark, DE. While the exact storage instructions are manufacturer-specific, compliance with their guidelines is critical to maintain assay integrity, as improper handling could compromise the reagent’s performance.