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ACCU-CHEK® FlexLink Plus is an infusion set for the subcutaneous infusion of insulin.

The ACCU-CHEK® FlexLink Plus is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.

Immunoassay for the in vitro quantitative determination of alpha fetoprotein (AFP) in human serum and plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Diagnostics/Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers. Immunoassay for the in vitro quantitative determination of alpha-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.

The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C). -1st incubation (9 minutes): Sample (30 µL), biotinylated monoclonal AFP- specific antibody (60 µL), and a monoclonal AFP-specific antibody labeled with a ruthenium complex (60 µL) react to form a sandwich complex. -2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (50 µL), the complex is bound to the solid phase via interaction of biotin and streptavidin. •The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). •Results are determined via a calibration curve which is instrument- specifically generated by 2-point calibration and a master curve provided via the reagent bar code.

The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheck™ Ferritin is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys Ferritin assay. Elecsys CalCheck Ferritin calibration verification solutions comprise three levels - low, mid, and high - each with a defined Ferritin concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range. The Elecsys CalCheck Ferritin is intended for use in periodic verification of the calibration of the Elecsys Ferritin assay.

The Roche Diagnostics/Boehringer Mannheim Elecsys® CalCheckTM Ferritin is manufactured using human serum albumin, Ferritin, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against ID-GC/MS.

The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys® CalCheck™ CA 125II is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CA 125II assay. Elecsys® CalCheck™ CA 125II calibration verification solutions comprise three levels - low, mid, and high - each with a defined CA 125II concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range. The Elecsys® CalCheck™ CA 125II is intended for use in periodic verification of the calibration of the Elecsys® CA 125II assay.

The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CalCheck CA 125II is manufactured using human serum albumin, CA 125, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against ID-GC/MS.