Reads RF Test Kit for IgM Rheumatoid Factor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K863238 ↗

FDA Product Code

DHR

Device Class

Class II

Regulation

21 CFR Part 866.5775

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Quantitative Assay for Det. of Igg Igm Anti-Dsdna

  Class II

  FDA 510(k) K893896 Active Cleared 14 Jul 1989

• Biostar* Reads* Immune Complex Assay Kit

  Class II

  FDA 510(k) K861499 Active Cleared 20 Jun 1986

• Semi-Quantitative Assay for Det. of Igg and Igm

  Class II

  FDA 510(k) K893897 Active Cleared 23 Jun 1989

• Biostar Re-a-Ds Immune Complex Assay Kit

  Class II

  FDA 510(k) K853697 Active Cleared 16 Dec 1985

• What is the Reads RF Test Kit for IgM Rheumatoid Factor used for?

  The Reads RF Test Kit is a semi-quantitative assay system designed to detect and measure the presence of IgM rheumatoid factor in patient samples. It is used in immunology testing procedures to help identify rheumatoid factor levels.

• How is the Reads RF Test Kit supplied and is it reusable?

  The test kit is supplied as a single-use device and is not intended for reuse. Each kit contains all necessary components for one test, and it should not be used for multiple patients or testing procedures.

• What regulatory approvals does the Reads RF Test Kit have?

  The Reads RF Test Kit has received FDA 510(k) clearance with the product code DHR. It is classified as a System, Test, Rheumatoid Factor and is authorized for use in immunology testing procedures in the United States.

• Is the Reads RF Test Kit compatible with MRI procedures?

  No, the Reads RF Test Kit is not indicated for MRI compatibility. The device should not be used in MRI environments as it may not function properly or pose safety risks under those conditions.