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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• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020) Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:

• Anti-Myoglobin Detection Kit

• Automated Hematology Analyzers

• Automated Homogeneous Liposome Immunoassay Systems

• Automated Immunoassay Systems

• Automated Urine Chemistry Analyzers

• Biochemistry Analyzers

• Blood Analyzer Reagents

• Blood Bank Software (FDA Code: MMH / 864.9175) An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.

• Blood Gas Analyzers

• Blood, Hematology Analyzers

• Cardiac Reader

• Chemistry Analyzers

• Cholesterol Analyzers

• Clinical Diagnostic Solutions, Hematology Reagents

• Clinical Immunochemistry Analyzers

• Clinical Sample Concentrator (FDA Code: JJH / 862.2310) A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed.

• Controls for Diagnostic Equipment

• Creatine Kinase Myoglobin Kit

• Customized Immunoassay Systems

• Detection Kits Myoglobin Detection Kit

• Diabetic Monitoring

• Direct Specimen of Methicillin Resistant Staphylococcus Aureus Dna Nucleic Acid Amplification Test System (FDA Code: NQX / 866.1640) An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

• Drug Metabolizing Enzyme Genotyping Systems (FDA Code: NTI / 862.3360)

• Flexible Laboratory Automation System

• General Diagnostic Supplies

• General Diagnostics

• General Examination Supplies

• General Medical Supplies

• Glucose Analyzers

• Hematology Analyzers

• Hematology Reagents

• Hematology Reagents and Kits

• Hematology Reagents and Kits Hemoglobin A1C (Glycohemoglobin)

• Hematology Reagents and Supplies

• Hepatitis B Viral DNA Detection (FDA Code: MKT)

• HIV Detection Test (FDA Code: MZF)

• HIV Screening - NAT

• HIV Viral Load and Genotype

• HIV-1 Test Monitor (FDA Code: MTL)

• Human Myoglobin ELISA Kits

• Hybridization And/Or Nucleic Acid Amplification Assay For Detection Of Hepatitis C Rna, Hepatitis C Virus (FDA Code: MZP)

• Immuno Chemistry Analyzers

• Immunoassay Equipment, Immunochemistry Analyzers

• Immunoassay Systems

• Immunochemistry Analyzers

• Immunoturbidmetric analyzers

• Infectious Disease Screening, HIV Screening - NAT

• Insulin Pump System

• Laboratory Automation Systems