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This CalCheck set is an assayed control for use in calibration and for use in the verification of the assay range established by the Elecsys ß-CrossLaps/serum reagent on the cobas e immunoassay analyzers.

The ß-CrossLaps CalCheck 5 is used for the calibration verification and the assessment of the measuring range as needed by the laboratory certification agencies such as College of American Pathologists or CLIA certification. The CalChecks are a customer convenience product and not required to assess the performance.

The Elecsys CYFRA 21-1 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CYFRA 21-1 reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The Elecsys CYFRA 21-1 CalCheck 5 is a lyophilized product consisting of cytokeratin in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. CYFRA 21-1 CalCheck 5 is a lyophilized human serum matrix with added cytokeratin in five concentration ranges. The CalCheck includes: - o CYFRA 21-1 CalCheck 1: approximately <1.0 ng/mL - CYFRA 21-1 CalCheck 2: approximately 3.0 ng/mL ● - CYFRA 21-1 CalCheck 3: approximately 50.0 ng/mL - CYFRA 21-1 CalCheck 4: approximately 80.0 ng/mL ● - CYFRA 21-1 CalCheck 5: approximately 100 ng/mL

Multichem Alc control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analyte, HbA1c, as listed in the package insert.

The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices. A minimum of two levels of control are available to allow performance monitoring within the clinical range of HbA1c assay method. Multichem A1c control is prepared from human red blood cells with added chemicals and stabilizers. The control is provided in liquid form for convenience.

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration, and the verification of reportable range for the glucose analyte. The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is for In Vitro Diagnostic use only.

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is an in-vitro diagnostic device consisting of sets of 5 levels of liquid, linearity material and additives in human based serum. The product contains the following analyte: glucose. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

The LIAISON® EBV IgM Serum Control Set (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBV IgM assay on the LIAISON® Analyzer family.

The LIAISON® EBV IgM Serum Control Set (negative and positive) consists of liquid ready-to-use controls in human serum. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens. The controls are designed for use with DiaSorin LIAISON® EBV IgM assay on the LIAISON® analyzer family.

The LIAISON® CMV IgM Serum Control Set (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® CMV IgM assay on the LIAISON® Analyzer family.

The LIAISON® CMV IgM Serum Control Set (negative and positive) consists of liquid ready-to-use controls in human serum. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens. The controls are designed for use with DiaSorin LIAISON® CMV IgM assay on the LIAISON® analyzer family.

IDS-iSYS 17-OH Progesterone Control Set The IDS-iSYS 17-OH Progesterone Control Set is for in vitro diagnostic use, for the quality control of the IDS-iSYS 17-OH Progesterone on the IDS-iSYS Multi-Discipline Automated System. Rx Only. IDS-iSYS 17-OH Progesterone Calibration Verifiers The IDS-iSYS 17-OH Progesterone Calibration Verifiers are an in vitro diagnostic device intended for medical purposes in the quantitative verification of assay calibration and measuring range of the IDS-iSYS 17-OH Progesterone assay, when performed on the IDS-iSYS Multi Discipline Automated System. Rx Only.

The IDS-iSYS 17-OH Progesterone Control Set consists of Two sets of three vials, 1.0 mL each in liquid form. Human serum containing 17-OH Progesterone and sodium azide as a preservative (<0.1%), with three concentration levels. The IDS-iSYS 17-OH Progesterone Calibration Verifiers consists of Four calibration verifier levels in liquid form (two 1.0mL vials for level 0 and one 1.0mL vial for levels 1, 2 & 3). Human serum containing 17-OH Progesterone and sodium azide as a preservative (<0.1%), with three concentration levels.

The Quantimetrix Dropper hsCRP High Sensivity CRP Control is intended for the quality control of laboratory testing procedures of high sensitivity C-Reactive protein (CRP). It is intended for professional in vitro diagnostic use only.

The Dropper® hsCRP Control is a ready-to-use liquid control that does not require reconstitution nor frozen storage. The product is supplied in three clinically significant levels filled to 1mL in convenient plastic dropper bottles. The controls are formulated in a human serum derived matrix fortified with preservatives and stabilizers to maintain product integrity and inhibit microbial growth. Each control level is formulated with human CRP antigen to clinically significant targets that are ideal to monitor high sensitivity CRP test methods.

CONTOUR®NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check to ensure that the Contour Next Blood Glucose Monitoring Systems are working properly.

Contour Next Control Solution is used as a quality control check to assure the customer that their Bayer Contour Next blood glucose monitoring system is reading accurately. The control solution has a very controlled amount of glucose in it. The bottles of Contour Next test strips have a range of acceptable values on every bottle that is used to compare the result obtained when the control solution is applied to the test strip. When the reading from the control solution is within the range on the bottle, the system has been quality control checked and shown to be accurate. If the reading from the control solution is outside the stated range, then the customer is instructed by the user guide to not use the system until trouble-shooting can be done and/or customer service is called for help. The Solution is a prescribed amount of glucose in water and includes a buffer, red dye, and a thickening agent. The control solution comes in a 2.5mL plastic bottle with an applicator tip. It comes in two glucose levels, Level 1 (about 45mg/dL) and Level 2 (about 125mg/dL).

The ADVIA Centaur® Follicle Stimulating Hormone (FSH) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur FSH assay. The ADVIA Centaur® Free thyroxine (FT4) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur FT4 assay. The ADVIA Centaur® Thyroxine (T4) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur T4 assay. The ADVIA Centaur® Triiodothyronine (T3) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur T3 assay.

ADVIA Centaur® FSH Master Curve Material is an in vitro diagnostic product containing various levels of follicle stimulating hormone spiked in lyophilized equine serum with sodium azide (0.1% after reconstitution) and preservatives. Each set contains eight levels (MCM1–8); with a reconstituted volume of 1.0 mL/vial per level. MCM1contains no analyte. The MCMs assigned values are lot-specific of target values: 0.00, 1.50, 4.50, 12.0, 30.0, 62.5, 130, 225 mIU/mL. ADVIA Centaur® FT4 Master Curve Material is an in vitro diagnostic product containing various levels of thyroxine in human plasma with sodium azide. Each set contains seven levels; with a reconstituted volume of 1.0 mL/vial per level. MCM1 contains no analyte. The FT4 MCMs assigned values are lot-specific of target values: 0.00, 2.00, 5.00, 10.0, 15.0, 22.0, and 35.0 µg/dL which corresponds to FT4 values of 0.00, 0.42, 0.80, 1.70, 3.0, 5.6, and 13.5 ng/dL. ADVIA Centaur® T4 Master Curve Material is an in vitro diagnostic product containing various levels of levothyroxine in human plasma with sodium azide and preservatives. Each set contains six levels; with a reconstituted volume of 1.0 mL/vial per level. MCM1 contains no analyte. The T4 MCMs assigned values are lot-specific of target values: 0.00, 2.50, 5.00, 10.0, 15.0. and 35.0 µg/dL. ADVIA Centaur® T3 Master Curve Material is an in vitro diagnostic product containing various levels of liothyronine in human plasma with sodium azide and preservatives. Each se contains seven levels; with a reconstituted volume of 1.0 mL/vial per level. MCM1 contains no analyte. The T3 MCMs assigned values are lot-specific of target values: 0.00, 0.42, 0.69, 1.11, 1.65, 3.87, and 7.00 ng/mL.