Immunogl. Frct. of Rabbit Antiser.-Igm

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

510(k) Number

K812487 ↗

FDA Product Code

DAO

Device Class

Class II

Regulation

21 CFR Part 866.5550

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

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• What is the immunoglobulin fraction of rabbit antiserum (IgM) used for?

  This device is designed for in vitro use in immunology assays to detect or quantify IgM antibodies in clinical samples. It aids in diagnosing conditions involving immune responses by helping identify the presence of IgM-specific antibodies, which are critical markers in certain infections, autoimmune diseases, and other immunological evaluations.

• How is the immunoglobulin fraction of rabbit antiserum supplied?

  The product is supplied as a fractionated antiserum, intended exclusively for laboratory use. It is not specified whether it is provided in liquid form, lyophilized, or another format, but standard laboratory practices for antiserum handling should be followed. No details on packaging sizes or quantities are provided.

• Is sterility or single-use information available for this antiserum?

  The provided data does not explicitly state whether this antiserum is sterile or intended for single-use. As with most laboratory reagents, it is typically handled under aseptic conditions, but users should follow standard laboratory protocols for antiserum to ensure safety and efficacy. No specific guidance on reuse is mentioned.

• What are the regulatory details for this device?

  This device was cleared under the FDA 510(k) process with the clearance number K812487. It was determined to be substantially equivalent to a predicate device through a traditional review by the Immunology (IM) Advisory Committee. The classification is Class II (device class 2), and it falls under the product code DAO, regulated under regulation number 866.5550.

• Are there any special storage instructions for this antiserum?

  The data does not provide specific storage instructions beyond general laboratory practices for antiserum. Typically, such reagents are stored frozen or refrigerated, protected from light, and handled with care to maintain their integrity. Users should consult the manufacturer’s guidelines or label instructions for precise storage recommendations.