(258 days)
The N-Assay TIA Multi V-NL Calibrator is intended to be used to calibrate the Crestat N-Assay TIA test Kits used To Carrorate the Orosas av C4 Test Kit, N-Assay Transferrin Test Kit, N-Assay Haptoglobin Test Kit, N-A66ay Alphael-Acid Glycoprotein Test Kit. The test kits are to be run on human serum.
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This document is a marketing approval letter from the FDA for a medical device (N-Assay TIA Multi V-NL Calibrator). It confirms that the device is substantially equivalent to previously marketed devices and can be sold. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information based solely on the text provided. This document is a regulatory approval, not a scientific study report.
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).