Advandx, Inc.

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Contact: Henrik Stender, Ph.D.
Web: http://www.advandx.com
E-Mail:
Address: 10a Roessler Road, Woburn, Massachusetts 01801, USA
Phone: +1-(781)-376-0009 | Fax: +1-(781)-376-0111 | Map/Directions >>

Profile: AdvanDx Inc. deals with molecular-based in-vitro diagnostic tests. Our molecular-based in-vitro diagnostic tests aid in the diagnosis and prevention of infectious diseases. We offer PNA Fish™ and Evigene™ diagnostic tests. Our PNA Fish™ and Evigene™ tests provide rapid identification results for bacteria & yeast to support appropriate antibiotic therapy and improve overall patient care. Our PNA Fish™ test is a rapid identification of positive blood cultures. We also offer Evigene™ that is a qualitative hybridization assay using signal amplification. It provides rapid detection of specific gene markers in S.aureus and enterococci isolates.

FDA Registration Number: 3004080598

19 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:

• Diagnostic Test Kits

• Enterobacteriaceae Identification Kit (FDA Code: JSS / 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.

• Enterococcus Faecalis Protein Nucleic Acid Fish (Fluorescent In Situ Hybridization) Kit (FDA Code: OAH / 866.3740)

• Heating Block (FDA Code: JRG / 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.

• In Vitro Immunodiagnostic Test Systems

• Incubator/ Water Bath (FDA Code: JTQ / 866.2540)

A microbiological incubator is a device with various chambers or water-filled compartments in which controlled environmental conditions, particularly temperature, are maintained. It is intended for medical purposes to cultivate microorganisms and aid in the diagnosis of disease.

• Infection Prevention Solutions

• Microscope Slide Coverslip (FDA Code: KES / 864.3010)

Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

• Microscope Slides (FDA Code: KEW / 864.3010)

• Molecular Diagnostic Services

• Quality Control Slide (FDA Code: LJG / 866.2660)

• Staphylococcus Aureus Rna Protein Nucleic Acid Fish (Fluorescent In Situ Hybridization) Kit (FDA Code: NXX / 866.3700)

• Staphylococcus Aureus Screening Kit (FDA Code: JWX / 866.2660)

• Streptococcus Spp Antiserum (FDA Code: GTZ / 866.3740)

• U.V Fluorescence Microscope (FDA Code: IBK / 864.3600)

Microscopes and accessories are optical instruments used to enlarge images of specimens, preparations, and cultures for medical purposes. Variations of microscopes and accessories (through a change in the light source) used for medical purposes include the following:

• Yeast Identification Kit (FDA Code: JXB / 866.2660)

• Yeast Rna Protein Nucleic Acid Fish (Fluorescent In Situ Hybridization) Kit (FDA Code: NZS / 866.2660)