BCM for cobas 8100 - India CDSCO Medical Device Registration

Product Information

BCM for cobas 8100 is a connection module intended to allow the automatic placement of sample tubes into single-sample holders and transfer from the Bulk Loader Module (cobas® 8000 data manager) for centrifuge unit cobas p 671 (cobas® 8000 data manager) to the cobas 8100 automated workflow series.,cobas u 411 system(cobas® 8000 data manager)-The cobas u 411 urine analyzer is a semi-automated, benchtop analyzer. It is designed to read the Combur10 Test M test strips for urinalysis. This analyzer is intended for the measurement of bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen and color (cobas® 8000 data manager). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Tests performed using the cobas u 411 are intended for prescription, in vitro diagnostic use only. Only trained personnel working in a professional laboratory environment may operate the cobas u 411 analyzer.,cobas t 711 coagulation analyzer(cobas® 8000 data manager)-"The cobas t 711 coagulation analyzer is a fully automated, discrete coagulation analyzer intended for the in vitro qualitative and quantitative determination of coagulation analytes in human citrated plasma, the results of which aid in the diagnosis of coagulation abnormalities and in monitoring anticoagulant therapy. The cobas t 711 coagulation analyzer is a standalone instrument and can also be connected to laboratory automation systems.",9180 Electrolyte Analyzer(cobas® 8000 data manager)-The 9180 Electrolyte Analyzer is intended to be used for measurements of sodium, potassium, ionized calcium and lithium in whole blood, serum or plasma, urine, dialysate solutions or QC materials as appropriate by minimally trained personal qualified to perform and to report these values in a clinical laboratory setting. These analytes are commonly used in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders.,cobas b 221 system(cobas® 8000 data manager)-The cobas b 221 system is a fully automated analyzer intended for In Vitro testing of samples of whole blood, serum, plasma, acetate and bicarbonate containing dialysis solutions and pleural fluid for the quantitative measurement of: o pH o Blood Gas (cobas® 8000 data manager): PO2, PCO2 o Electrolyte (cobas® 8000 data manager): Na+, K+, Cl-, iCa2+ o Hematocrit (cobas® 8000 data manager) o Metabolites (cobas® 8000 data manager): Glucose, Lactate, Urea/BUN (cobas® 8000 data manager) o Total Hemoglobin (cobas® 8000 data manager) o Oxygen saturation (cobas® 8000 data manager) o Hemoglobin derivative COOX (cobas® 8000 data manager) o Bilirubin (cobas® 8000 data manager) In addition, the cobas b 221 system calculates derived parameters. The following parameters can be measured in whole blood, serum or plasma: o pH o Blood Gas (cobas® 8000 data manager): PO2, PCO2 o Electrolyte (cobas® 8000 data manager): Na+, K+, Cl-, iCa2+ o Hematocrit (cobas® 8000 data manager) o Metabolites (cobas® 8000 data manager): Glu, Lac, Urea/BUN o Total hemoglobin (cobas® 8000 data manager) o Oxygen saturation (cobas® 8000 data manager) o Hemoglobin derivative COOX (cobas® 8000 data manager) o Bilirubin (cobas® 8000 data manager) The following parameter can be measured in pleural fluid: o pH,cobas t 511 coagulation analyzer(cobas® 8000 data manager)-"The cobas t 511 coagulation analyzer is a fully automated, random continuous-access, software controlled system for clotting, chromogenic and immunoturbidimetric analysis intended for qualitative and quantitative in vitro coagulation determinations using a wide variety of coagulation tests, the results of which aid in the diagnosis of coagulation abnormalities and in monitoring anticoagulant therapy. The cobas t 511 coagulation analyzer is a system that uses human citrated plasma for the determination of coagulation analytes."