Cepheid

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Web: http://www.cepheid.com
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Address: 904 Caribbean Drive, Sunnyvale, California 94089-1189, USA
Phone: +1-(408)-541-4191 | Fax: +1-(408)-541-4192 | Map/Directions >>

Profile: Cepheid is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests for genetic analysis in the clinical, industrial & biothreat markets. Our systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. We focus on food, agricultural, and environmental testing in the industrial market. Our automated GeneXpert® infinity system delivers a complete all-in-one molecular diagnostics system to healthcare institution.

FDA Registration Number: 3004530258

11 Products/Services (Click for related suppliers)

• 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:

• Clostridium Difficile Toxin Reagent (FDA Code: LLH / 866.2660)

A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

• 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.

• Direct Specimen Test of Group B Streptococcus Nucleic Acid Amplification Assay System (FDA Code: NJR / 866.3740)

• Enterovirus Nucleic Acid Assay (FDA Code: OAI / 866.3225)

• Genomic Dna Pcr Factor Ii G20210a Mutations Test (FDA Code: NPR / 864.7280)

Factor V Leiden deoxyribonucleic acid (DNA) mutation detection systems are devices that consist of different reagents and instruments which include polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection of the Factor V Leiden mutation aids in the diagnosis of patients with suspected thrombophilia.

• Genomic Dna Pcr Factor V Leiden Mutations Test (FDA Code: NPQ / 864.7280)

• Invitro Diagnostic Potentiating Media (FDA Code: KSG / 864.9600)

Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.

• Molecular Analyte Specific Reagents (ASR)

• Molecular Diagnostic Services

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