Dimension Vista Intelligent Lab System

Siemens Material Number (SMN): 10284473, 10488224, 10444801, 10444802

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - Nationwide Distribution including Puerto Rico., and the countries of : Austria, Australia, Belgium, Canada, Denmark, France, Finland, Germany, Japan, Italy, New Zealand, Netherlands, Czech Republic, Portugal, Republic Korea, Norway, Spain, Switzerland, Slovakia, Saudi Arabia, Slovenia, and United Kingdom,

Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.

Device Listing D011374 Serial Number: All serial numbers

Clinical Chemistry and Clinical Toxicology Devices

1

No

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

Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use || Product Usage: || The Siemens Healthcare Diagnostics Dimension Vista System is 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. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.

Dimension Vista Intelligent Lab Systems with Software v.3.7 or v.3.8.1. An in vitro diagnostic medical device (IVD) Dimension Vista 500 Intelligent Lab System Siemens Material Number (SMN): 10488217 and 10488224 Dimension Vista 1500 Intelligent Lab System Siemens Material Number (SMN): 10444802 and 10459469

Instrument/analyser IVDs

Product: Millipore Progard Pretreatment Pack Siemens Material Number (SMN): 10450564 Lot Numbers: F7MA56608, F7MA50339, F7NA62488, F8AA93567, F8HA64477, F8AA13966, F8HA79819, F8BA20457, F8BA35774, F8DA59251, F8HA91305, F8JA97876, F8MA06374 ........................ TGA update codes: Dimension Vista Lab Systems: 10488217, 10488224, 10444802, 10459469

Instrument/analyser IVDs

Dimension Vista 500 Siemens material numbers: 10284473 (domestic), and 10488224 (international), Dimension Vista 1500 Siemens material numbers: 10444801 (domestic) and 10444802 (international).

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution: US (nationwide) including PR and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudia Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, and United Kingdom.

Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. || 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. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion-selective multisensory technology for clinical use.