Abaxis Placement Papers - Abaxis Interview Questions and Answers updated on Dec 2024
At Abaxis our mission is to supply point of care blood analyzers to the medical market and the veterinarian market. Abaxis provides leading edge technology, tools and services that support best medical practices, enabling physicians and veterinarians to respond to the health needs of their clients at the point of care while operating economical and profitable practices. Abaxis is headquartered in northern California, USA, and conducts operations around the world.
The Abaxis Laboratory System consists of a compact, chemistry analyzer capable of electrolytes, blood gas and immunoassays, a complete easy to use hematology analyzer and a series of 8-cm diameter single-use plastic discs, called reagent rotors, which contain all the necessary reagents to perform a fixed menu of tests. The System can be operated with minimal training and perform multiple tests on whole blood, serum or plasma. The System provides test results in minutes with the precision and accuracy equivalent to a clinical laboratory.
The Abaxis Quality Policy
Abaxis' management is committed to maintaining a robust Quality System, being a leader in innovation, and developing, producing, and delivering save, effective, high quality diagnostic products and services that meet or exceed our customer expectations, on time, every time. We achieve these objectives through compliance with all applicable regulatory requirements, adopting industry best business practices, and operating in the spirit of continuous improvement.
Abaxis is licensed as a medical device manufacturer in accordance with the FDA Quality System Regulation. Abaxis is also certified to the ISO 13485:2003 Quality System Standard for medical devices.
History
The genesis of the Abaxis technology took place at the Oak Ridge National Laboratory, where under contract to the National Aeronautics and Space Administration (NASA),scientists sought to develop and manufacture a small biochemical analyzer for use in space laboratories.
Abaxis was founded in April 1989. Shortly thereafter, Abaxis acquired the exclusive patent rights from Oak Ridge National Laboratory, to develop and manufacture a biochemical analyzer that was capable of performing multiple blood tests from a single drop of whole blood. In 1992, Abaxis completed the concept design for the then-named "EPOC 2000" system.
To be able to measure multiple parameters from a very small quantity of whole blood, Abaxis developed the Orbos technology. This technology allows the manufacturing of stable reagents in minute quantities with extraordinary precision. In September 1994, Abaxis entered into a supply agreement with Becton Dickinson to provide them with immunochemical reagents in the Orbos format. Today, Abaxis licenses and manufactures reagents utilizing the Orbos technology to other companies.
The Piccolo analyzer was introduced to the market in November 1995 with two reagent discs; Primary Health Panel, a nine-test reagent disc and a General Health Panel, a 12-test reagent disc. With the 510(k) clearance of the GGT test from the FDA, the Liver Panel Plus disc was introduced in November 1996. Since then, Abaxis has added new tests and reagent discs to fulfill different physicians' needs.
The VetScan analyzer was introduced in the US veterinary market in July 1995. Abaxis initially launch the analyzer with the Diagnostic Profile, a nine-test reagent rotor. Since then Abaxis has added 14 different assays and eight different profiles targeted to fulfill different veterinary diagnostic needs.
Currently, Abaxis covers more than 90% of the general chemistry tests normally used in medical and veterinary diagnostics.
The Abaxis Laboratory System consists of a compact, chemistry analyzer capable of electrolytes, blood gas and immunoassays, a complete easy to use hematology analyzer and a series of 8-cm diameter single-use plastic discs, called reagent rotors, which contain all the necessary reagents to perform a fixed menu of tests. The System can be operated with minimal training and perform multiple tests on whole blood, serum or plasma. The System provides test results in minutes with the precision and accuracy equivalent to a clinical laboratory.
The Abaxis Quality Policy
Abaxis' management is committed to maintaining a robust Quality System, being a leader in innovation, and developing, producing, and delivering save, effective, high quality diagnostic products and services that meet or exceed our customer expectations, on time, every time. We achieve these objectives through compliance with all applicable regulatory requirements, adopting industry best business practices, and operating in the spirit of continuous improvement.
Abaxis is licensed as a medical device manufacturer in accordance with the FDA Quality System Regulation. Abaxis is also certified to the ISO 13485:2003 Quality System Standard for medical devices.
History
The genesis of the Abaxis technology took place at the Oak Ridge National Laboratory, where under contract to the National Aeronautics and Space Administration (NASA),scientists sought to develop and manufacture a small biochemical analyzer for use in space laboratories.
Abaxis was founded in April 1989. Shortly thereafter, Abaxis acquired the exclusive patent rights from Oak Ridge National Laboratory, to develop and manufacture a biochemical analyzer that was capable of performing multiple blood tests from a single drop of whole blood. In 1992, Abaxis completed the concept design for the then-named "EPOC 2000" system.
To be able to measure multiple parameters from a very small quantity of whole blood, Abaxis developed the Orbos technology. This technology allows the manufacturing of stable reagents in minute quantities with extraordinary precision. In September 1994, Abaxis entered into a supply agreement with Becton Dickinson to provide them with immunochemical reagents in the Orbos format. Today, Abaxis licenses and manufactures reagents utilizing the Orbos technology to other companies.
The Piccolo analyzer was introduced to the market in November 1995 with two reagent discs; Primary Health Panel, a nine-test reagent disc and a General Health Panel, a 12-test reagent disc. With the 510(k) clearance of the GGT test from the FDA, the Liver Panel Plus disc was introduced in November 1996. Since then, Abaxis has added new tests and reagent discs to fulfill different physicians' needs.
The VetScan analyzer was introduced in the US veterinary market in July 1995. Abaxis initially launch the analyzer with the Diagnostic Profile, a nine-test reagent rotor. Since then Abaxis has added 14 different assays and eight different profiles targeted to fulfill different veterinary diagnostic needs.
Currently, Abaxis covers more than 90% of the general chemistry tests normally used in medical and veterinary diagnostics.
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