Celera

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Contact: Paul Arata - vice President
Web: http://www.celeradiagnostics.com
E-Mail:
Address: 1401 Harbor Bay Parkway, Alameda, California 94502-7070, USA
Phone: +1-(510)-749-4200 | Map/Directions >>

Profile: Celera is a healthcare company focused on personalizing disease management through diagnostic products and services. Our product categories include infectious diseases, genetics & proteomics, transplantation and systems. Our ViroSeq HIV-1 genotyping system has been cleared by the FDA, and is CE marked for use in detecting HIV genomic mutations that confer resistance to specific types of anti-retroviral drugs, as an aid in monitoring and treating HIV infection. It can be used for managing therapy changes in HIV-1 infected patients whose drug regimen has failed, and in HIV-1 infected individuals at initial presentation, before starting treatment. Our cystic fibrosis genotyping assay is a qualitative in vitro diagnostic device used to genotype a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA, that is isolated from human whole blood specimens.

The company was founded in 1998, has ~540 employees.

16 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:

• Gene Mutation Detection, Cystic Fibrosis Transmembrane Conductance Regulator System (FDA Code: NUA / 866.5900)

• General Purpose Reagent (FDA Code: LDT)

• HIV Screening - NAT

• HIV-1 Genotyping Testing System

• Hla-dqb Typing Kit (FDA Code: MVS / 866.5660)

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

• In Vitro Hiv Drug Resistance Genotype Assay (FDA Code: NHS / 866.3950)

• Infectious Disease Screening, HIV Screening - NAT

• Labeled Medical Laboratory Equipment (FDA Code: LXG / 862.2050)

General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• Laboratory Equipment

• Laboratory Equipment Devices

• Molecular Analyte Specific Reagents (ASR)

• Non-Diagnostic Qualitative Test For Hla (FDA Code: MZI)

• Paraquat Assay (FDA Code: LTD)

• Sterile Absorbent Tipped Applicator (FDA Code: KXG / 880.6025)

An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.

• Sterile Specimen Mailer and Storage Container (FDA Code: KDT / 864.3250)

A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.