Dimension Vista

lots 12300BB, exp. 10-26-2013; 12318BB, exp. 11-13-2013; and 13011BB, exp. 1-11-2014.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA (nationwide) and Canada.

Dimension Vista Cyclosporine Flex reagent cartridge || an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients.

lot 3FD034, exp. 6/17/2014, and lot 3HD012, exp. 9/1/2014.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. || An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

CSA 13114BA, exp. 2014-04-24; CSA 13157BA, exp. 2014-06-06; CSA 13246BB, exp. 2014-09-03; CSA 13317BA, exp. 2014-11-13; CSA 14008BB, exp. 2015-01-08; CSA 14050BB, exp. 2015-02-19; CSAE 13157BC, exp. 2014-06-06; CSAE 13249BD, exp. 2014-09-06.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Belgium, Switzerland, Germany, Spain, France, Great Britain, Italy, Saudi Arabia, Australia, and Japan.

Dimension Vista¿ CSA and CSAE || The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

lot 3JD045, exp. 2014-10-01; lot 4BD064, exp. 2015-02-01; lot 4CD012, exp. 2015-03-01; and lot 4DD065, exp. 2015-05-01.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwided distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Canada, Denmark, Germany, Finland, France, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, Slovenia, South Korea, Spain, and Switzerland.

Dimension Vista¿ Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista¿ System.

Material Nos.: 10284473, 10488224,  10444801, and 10444802

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, and United States.

Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: || An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.