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The ST AIA-PACK hsE2 Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK hsE2 assay.

- 2 x 1 mL ST AIA-PACK hsE2 Calibrator (1) 0 pg/mL Human serum containing no detectable concentration of estradiol with sodium azide as a preservative. - 2 x 1 mL ST AIA-PACK hsE2 Calibrator (2) 25 pg/mL (approx.) - ST AIA-PACK hsE2 Calibrator (3) 50 pg/mL (approx.) - ST AIA-PACK hsE2 Calibrator (4) 100 pg/mL (approx.) - ST AIA-PACK hsE2 Calibrator (5) 500 pg/mL (approx.) - ST AIA-PACK hsE2 Calibrator (6) 1,100 pg/mL (approx.) Human serum containing the assigned concentration of estradiol (described on each vial) with sodium azide as a preservative. ST AIA-PACK hsE2 Calibrator Set P/N # 025325 The ST AIA-PACK hsE2 Calibrator Set is designed specifically for use on the Tosoh AIA System Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials. The ST AIA-PACK hsE2 Calibrator Set is designed for use with ST AIA-PACK hsE2 and ST AIA-PACK hsE2 Sample Diluting Solution.

Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva and serum. Measurements obtained by this device may be used in the diagnosis and treatment of various hormonal sexual disorders and can be used to evaluate ovarian function. This test is not intended for assessing placental function in complicated pregnancy.

Luminescence immunoassay (LIA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.

The DPC IMMULITE 1000 is an automated immunoassay system intended to assay the same broad range of analytes in patient samples as does IMMULITE. The intent of the system is to impart the same automation to the array of immunoassays in the same hospital and commercial laboratory settings as IMMULITE. The system is intended to produce safe and effective performance when used by medical laboratory personnel as is the IMMULITE predicate system.

The DPC IMMULITE 1000 product is essentially an upgrade of the current IMMULITE system. All of the current functionality will be retained; however, the system will be enhanced with regard to the user interface, casework, and system footprint. The operating system will be changed to a Windows 2000 environment. In addition, the system will be remodeled to give the IMMULITE a more "modern" look and feel to be part of the "IMMULITE Family". Finally, the total system footprint will be decreased by such mechanisms as integrating the PC into the architecture of the system and provide a defined area for storing bulk materials (i.e., waste, water, and, probe wash).