Biocheck IgE ELISA, Model BC-1035

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

510(k) Number

K992528 ↗

FDA Product Code

DGC

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K991741 Active Cleared 22 Jul 1999

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• Biocheck Cardiac-1 Crp Rapid Test, Model Bc-804114

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• Biocheck Testosterone Eia, Model Bc-1115

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See all devices from Biocheck, Inc. →

• What is the Biocheck IgE ELISA BC-1035 used for?

  The Biocheck IgE ELISA Model BC-1035 is used for the quantitative measurement of immunoglobulin E (IgE) in human serum. It aids in the assessment of hypersensitive and allergic reactions when used by trained personnel in clinical laboratory settings.

• How is the Biocheck IgE ELISA BC-1035 supplied and what is its regulatory status?

  The device is supplied as a test kit and is regulated under FDA 510(k) clearance K992528, with a substantially equivalent decision issued on September 21, 1999. It is classified as a Class II device under product code DGC and regulation number 866.5510.

• Is the Biocheck IgE ELISA BC-1035 sterile or single-use?

  The source data does not provide information regarding the sterility, single-use, or reusable status of the Biocheck IgE ELISA Model BC-1035. Users should consult the product labeling or manufacturer’s instructions for details on handling and use.