Tech. Ra-1000SYS-Analytes Immunoglobulin

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K833402 ↗

FDA Product Code

DEW

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the Tech. RA-1000SYS Analytes Immunoglobulin used for?

  This system is designed for the quantitative measurement of immunoglobulins (IgG, IgA, IgM, IgD, and IgE) in patient samples. It aids clinical immunology laboratories in detecting and precisely quantifying antibody levels, which helps in diagnosing and monitoring immune-related conditions.

• How is the Tech. RA-1000SYS Immunoglobulin Test System supplied?

  The device is supplied as a kit containing the necessary reagents for testing, including antigen, antiserum, and control reagents. These components work together to facilitate serological analysis in a clinical setting.

• Is the Tech. RA-1000SYS Immunoglobulin Test System single-use or reusable?

  The available regulatory records do not explicitly state whether the system is single-use or reusable. Laboratories should follow their internal protocols and manufacturer guidelines for proper usage and disposal.

• What regulatory approval does the Tech. RA-1000SYS Immunoglobulin Test System hold?

  The device was cleared by the FDA under 510(k) number K833402, classified under product code DEW and regulation 21 CFR 866.5510. It was determined to be substantially equivalent to a predicate device and reviewed by the Immunology (IM) advisory committee.

• Are there specific storage instructions for the Tech. RA-1000SYS Immunoglobulin Test System?

  The regulatory records do not provide explicit storage instructions for this device. Laboratories should refer to the manufacturer’s instructions or documentation included with the kit for proper storage conditions to maintain reagent integrity and test accuracy.