Profile: Roche Molecular Systems, Inc markets various products for the prevention, diagnosis, evaluation and monitoring of diseases. Our amplichip CYP450 test gives a comprehensive coverage of gene variations that include deletions and duplications for the CYP2D6 & CYP2C19 genes, which play a major role in the metabolism of an estimated 25% of all prescription drugs. Our accu check inform system is user-friendly, hand-held system for point of care glucose testing and monitoring in hospitals. It allows entry and automatic transfer of manual test information. Our accu chek spirit insulin pump system is A convenient and reliable insulin pump that offers a new level of flexibility in insulin pump therapy.

FDA Registration Number: 3004141078

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• Laboratory Hematology Analyzers

• Medical Management Software

• Micro Chemistry Analyzer (FDA Code: JJF / 862.2170) A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

• Microalbumin Urine Test Kits

• Modular Laboratory Automation System

• Molecular Analyte Specific Reagents (ASR)

• Multichannel Hematology Analyzers

• Multiple Immunoassay Systems

• Mycobacterium Tuberculosis Complex Nucleic Acid Amplification System (FDA Code: MWA / 866.3372)

• Myoglobin (FDA Code: DDR / 866.5680) A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

• Myoglobin Enzyme Immunoassay Test Kit

• Myoglobin Radioimmunoassay Reagent Kits

• Myoglobin Ria Test Kit

• Neisseria DNA Reagents (FDA Code: LSL / 866.3390)

• Nucleic Acid Amplification Test for Chlamydia (FDA Code: MKZ / 866.3120) Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

• POC Cardiac Marker Analyzers

• POC Cardiac Marker Analyzers, RAMP System

• Real Time Nucleic Acid Amplification System (FDA Code: OOI / 862.2570)

• Refurbished Hematology Analyzers

• Sensitive Immunoassay Systems

• Smaller Hematology Analyzers

• Sodium Potassium Analyzers

• Staphylococcus PCR Kit

• Substrates For Immunoassay Systems

• Transfection Reagent

• Urine Chemistry Analyzers