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The ETI-MAX 3000™ is a fully automated microtiter plate analyzer designed to perform the complete sample processing of qualitative and semi-quantitative assays with respect to (sample dilutions, sample and reagent dispensing, incubations, wash processes, plate transports) as well as the photometric measurement and evaluation. The qualitative and semi-quantitative performance of the ETI-MAX 3000 ™ instrument were assessed using the DiaSorin ANAScreen ELISA kit, the DiaSorin Anti-SS-A (Ro) ELISA kit and the EuroDiagnostica AB ENA Single Well Screen Kit.

The ETI- MAX 3000™ is a fully automated, microtiter plate laboratory analyzer performing the complete sample processing (barcode scanner, predilution station, pipetting station, plate transport, wash station, incubators and photometric measurement). The instrument is controlled by the Windows PC software ETI- MAX 3000™. This software allows the user to process the pre-defined assays of DiaSorin.

The Polymedco SpotChem EX and ALT test system is an in vitro diagnostic instrument and procedure intended to measure the activity of the enzyme alanine amino transferase or ALT (also know as a serum glutamic pyruvic transaminase or SGPT) in serum, plasma and whole blood. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

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The LightCycler Instrument is a fully automated amplification and detection system for nucleic acids using fluorescence detection. The LightCycler is intended to be used by laboratory professionals trained in laboratory techniques and on the use of the analyzer.

The LightCycler Instrument consists of a microvolume fluorimeter integrated with a thermal cycler. It combines rapid-cycler PCR in glass capillaries heated with hot-air with real-time fluorescence monitoring. The system is designed to reduce the time needed to achieve results from PCR and to enable the user to monitor the amplification of the PCR product simultaneously, in real-time and on-line.

The Precision Systems ANALETTE Chemistry Analyzer is intended for the quantitative determination of analytes in solutions, such as serum, plasma, or urine. It is an "open" system, which can use a variety of commercially manufactured reagents, such as, but not limited to Synermed's Reagents for Albumin, ALT, AST, ALP, Amylase, Calcium, CO2, Cholesterol, Creatinine, CK, Glucose, GGT, LDH, Maqnesium, Phosphorus, Total Protein, Triglycerides, Urea Nitrogen, Total Bilirubin, Direct Bilirubin, HDL Cholesterol, UBIC, Iron, Chloride, and Uric Acid as shown in 510(k) K971491 using the ANALETTE under Synermed's name IR 200

An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.

The COBAS TaqMan Analyzer is a fully automated amplification and detection system for nucleic acids using 5' nuclease technology. The COBAS TaqMan Analyzer is intended to be used by laboratory professionals trained in laboratory techniques and on the use of the analyzer.

The COBAS TaqMan Analyzer is a flexible, automated batch analyzer that automates the real-time kinetic amplification and detection steps of the Polymerase Chain Reaction (PCR) process. The COBAS TaqMan Analyzer combines the operations of automated handling of reaction tubes (K-Tubes), thermal cycling, controlled temperature incubation, real-time photometric detection at each cycle and result reporting into a single automated analyzer. The instrument consists of four major sub-components: (1) a thermal cycler module; (2) a robotic transfer unit; (3) a photometer module and (4) a workstation, which together with an on-board real-time processor controls and monitors the major components including system and run control, results calculation, and system diagnostic tests and provides the user interface.

The CARESIDE Analyzer is an in vitro diagnostic instrument intended for the measurement of various clinical chemistry analytes in human whole blood, plasma, or serum. For in vitro diagnostic use. For point of care use.

The CARESIDE Analyzer is a compact chemistry instrument that performs multiple discrete analyses on human whole blood, plasma, or serum samples. The CARESDIDE Analyzer is semi-automated: the only operator steps are the addition of the sample to the test cartridge and the insertion of the dosed cartridge into the instrument. The CARESIDE Analyzer automatically warms, separates, meters, dispenses, and incubates the sample before reading the signal and calculating results. The CARESIDE Analyzer is intended only for use with CARESIDE test cartridges. The instrument is controlled through a touch-screen interface. Results are displayed on the interface screen. Results can also be downloaded on to a 3-1/2 inch diskette or to a computer via a RS-232 port. The CARESIDE Analyzer accepts up to 6 test cartridges from a single patient at the same time.

This notification is for an in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

A random access, automated Clinical Micro-Chemistry Analyzer with a throughput of up to 180 test per hour which is intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry. monitoring drugs of abuse and in therapeutic drug monitoring.

This product is intended for use with Exigent Diagnostics Cartridges when used by laboratory professionals for the in vitro measurement of various clinical chemistry analytes in human blood. This product is indicated for in vitro measurement of various clinical chemistry analytes in human blood.

The Exigent Diagnostics CareSide™ System utilizes individual (analyte specific) test cartridges to perform a variety of clinical blood tests. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer. The Exigent Diagnostics CareSide™ Analyzer automatically performs up to 6 quantitative test results in approximately ten minutes using approximately 85 microliters of human blood per test. Results are provided on-screen, and may be transferred to a floppy disk for subsequent uploading to a laboratory information system. The Exigent Diagnostics CareSide™ System components include: CareSide™ Analyzer and Analyte-specific Cartridge(s). The CareSide™ Analyzer is a compact tabletop chemistry analyzer that performs multiple discrete analyses on human whole blood, plasma, or serum specimens. The CareSide™ analyzer is semi-automated: the only operator intervention is the addition of the specimen to the test cartridge and the insertion of the dosed cartridge into the analyzer. The CareSide™ Analyzer automatically warms, separates, meters, dispenses, and incubates the specimen before reading the signal and calculating results. The CareSide™ Analyzer is intended only for use with Exigent Diagnostics CareSide™ test cartridges.

The MAGO is intended to be used as a general purpose automated EIA processor. The MAGO is indicated for use in moderate complexity laboratories for performing automated EIA procedures. The Diamedix MAGO is indicated for use as a general purpose automated EIA processor for use in clinical laboratories.

The MAGO and its predicates all share the same principle of operation. Each device provides a pipetting station which is capable of performing normal pipetting functions such as, accurately aspirating and dispensing fluids into microplates and a wash station capable of simulating a microplate washing device. The device allows user programming which controls the sequence of activity to allow sample dilution and addition, incubation, and reagent dispensing which mimics and duplicates manual assay procedures.

The Synermed® IR200™ analyzer is intended for in vitro diagnostic use as a multiparameter biochemistry instrument that sequentially quantitates levels of constituents in serum, plasma or urine. Testing is selective, i.e, only selected tests or profiles or automatic repeats of selected tests are performed on each sample. The Synermed IR200 analyzer is specifically designed to perform tests with Synermed reagents or reagent applications recommended by Synermed. Consequently, no representation as to the general utility of the Synermed IR200 with other than Synermed reagents or approved applications is made and none should be inferred.

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