Qaca Igg/Igm Elisa Kit

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K020241 ↗

FDA Product Code

MID

FDA applicant

Cheshire Diagnostics , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• QAB2A Igg Elisa Kit Hrp

  Class II

  FDA 510(k) K021611 Active Cleared 12 Jul 2002

• QAB2A Igg Elisa Kit

  Class II

  FDA 510(k) K020695 Active Cleared 19 Apr 2002

• Qaca Igg/Igm Elisa Kit Hrp

  Class II

  FDA 510(k) K021192 Active Cleared 16 May 2002

• QAB2A Igm Elisa Kit Hrp

  Class II

  FDA 510(k) K021610 Active Cleared 12 Jul 2002

• QAB2A Igm Elisa Kit

  Class II

  FDA 510(k) K020694 Active Cleared 19 Apr 2002

• What is the QACA IgG/IgM ELISA Kit used for?

  This kit is designed for the semi-quantitative detection of IgG and IgM antibodies to cardiolipin in human serum. It helps assess markers associated with antiphospholipid syndrome, a condition linked to autoimmune-related blood clotting disorders. The ELISA method measures antibody levels, providing clinical insights for immunology testing.

• Is the QACA IgG/IgM ELISA Kit sterile?

  No, the QACA IgG/IgM ELISA Kit is not sterile. It is supplied as a single-use diagnostic tool and requires preparation according to the included instructions before use. Sterility is not a feature of this device, as it is intended for laboratory use where aseptic technique is applied during testing.

• How is the QACA IgG/IgM ELISA Kit supplied?

  The kit is supplied as a single-use diagnostic tool, meaning each kit is intended for one testing procedure. It does not require sterilization before use, but proper handling and preparation as outlined in the instructions are necessary to ensure accurate results. The kit is designed for clinical laboratory settings.

• What regulatory clearance does the QACA IgG/IgM ELISA Kit hold?

  The QACA IgG/IgM ELISA Kit holds FDA 510(k) clearance under the reference number K020241. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and adheres to regulatory standards for immunological testing. It is classified as a Class II medical device.

• Are there specific storage conditions mentioned for the QACA IgG/IgM ELISA Kit?

  The provided data does not specify any particular storage conditions for the QACA IgG/IgM ELISA Kit. Users should follow general laboratory practices for storing diagnostic reagents, typically involving protection from extreme temperatures, light, and contamination. Always refer to the included instructions for any additional guidance.