Rabbit Antiserum to Human IgA

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K831909 ↗

FDA Product Code

CZN

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Rabbit Antiserum to Human C4

  Class II

  FDA 510(k) K831906 Active Cleared 19 Jul 1983

• Dako Pap Kit K504

  Class II

  FDA 510(k) K812485 Active Cleared 10 Feb 1982

• Staining System for Pneumocystis Carinii

  Class II

  FDA 510(k) K905504 Active Cleared 28 Jun 1991

• Dako Monoclonal Mouse Anti-Human Estrogen Receptor

  Class II

  FDA 510(k) K993957 Active Cleared 3 Mar 2000

• Dako Elisa Rotavirus Kit- 96 Tests K440

  Class I

  FDA 510(k) K912666 Active Cleared 14 Feb 1992

• Rabbit Antiserum to Human Kappa Light

  Class II

  FDA 510(k) K831904 Active Cleared 19 Jul 1983

See all devices from Dako Corp. →

• What is the rabbit antiserum to human IgA used for?

  This antiserum is designed for use in immunohistochemistry to detect human IgA antigens in tissue samples. It helps clinicians evaluate conditions involving IgA deposition, such as certain autoimmune diseases or deficiencies, by identifying the presence of IgA in paraffin-embedded sections during laboratory testing.

• How is the rabbit antiserum to human IgA supplied?

  The product is supplied as a non-conjugated antiserum, meaning it is not pre-linked to a fluorescent or enzymatic marker. It is intended for single-use in vitro diagnostic applications, ensuring each vial is used once for accurate and reliable testing in laboratory settings.

• Is the rabbit antiserum to human IgA sterile?

  The regulatory data does not explicitly specify sterility requirements for this product. However, as a Class II medical device regulated under FDA 510(k) clearance, it is expected to meet general industry standards for sterility in laboratory reagents. Always follow manufacturer guidelines for handling and storage to ensure safety.

• Can this antiserum be reused?

  No, this rabbit antiserum to human IgA is intended for single-use only. Reusing the product could compromise accuracy and reliability in detecting IgA in tissue samples, potentially leading to incorrect diagnostic results. Each vial should be used once and discarded.

• What regulatory approval does this device hold?

  The rabbit antiserum to human IgA holds an FDA 510(k) clearance under the reference number K831909, classified under product code CZN. This clearance indicates that the device is substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness in its intended use for immunohistochemistry.