Biogenex Laboratories

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Contact: Dr. Krishan Kalra - President & CEO
Web: http://www.biogenex.com
E-Mail:
Address: 4600 Norris Canyon Road, San Ramon, California 94583-1320, USA
Phone: +1-(925)-275-0550, 800-421-4149 | Fax: +1-(925)-275-0580 | Map/Directions >>

Profile: Biogenex Laboratories specializes in the field of molecular diagnostics. We support cellular & molecular pathology laboratories with a range of reagents, detection kits, antibodies, probes, special stains and automated staining & imaging systems. Our BioGenex EZ-Retriever® system v.2, is a microwave-based time and temperature controlled system specifically designed to unmask the antigens on the formalin-fixed, paraffin-embedded (FFPE) tissue sections. It is used in dewaxing, rehydration for all tissue preparations and antigen retrieval & nucleic acid retrieval for formalin-fixed, paraffin-embedded tissue sections. Our Super Sensitive™ polymer-HRP IHC detection system facilitates production of staining results with minimum background especially in those tissues which have high level of endogenous biotin. This method is used in lieu of streptavidin-biotin thus eliminating background that can be caused by endogenous biotin.

The company was founded in 1981, has revenues of USD 10-25 Million, has ~120 employees and is ISO 9001, CE certified.

FDA Registration Number: 3008776165

39 Products/Services (Click for related suppliers)

• Alcian Blue Stain (FDA Code: IDA / 864.1850)

Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

• 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:

• Automated Slide Stainer (FDA Code: KPA / 864.3800)

An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

• Automated Tissue Processor (FDA Code: IEO / 864.3875)

An automated tissue processor is an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.

• Automated Tissue Stainer (FDA Code: KEY / 864.3800)

• Carbol Fuchsin Stain (FDA Code: ICL / 864.1850)

• Congo Red Stain (FDA Code: ICH / 864.1850)

• Dye Solution Stain (FDA Code: LEE / 864.1850)

• Estrogen Receptor Antibody Immunohistochemistry Assay (FDA Code: MYA / 864.1860)

Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

• Formulations Paraffin (FDA Code: KEO / 864.4010)

• General Purpose Reagent (FDA Code: LDT)

• Giemsa Stain (FDA Code: HYF / 864.1850)

• Hematoxylin Stain (FDA Code: HYJ / 864.1850)

• Imaging Systems

• Immunohistochemistry Reagents And Kits (FDA Code: NJT / 864.1860)

• Iron Stain (FDA Code: GGH / 864.1850)

• 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.

• Mallory's Trichrome Stain (FDA Code: HYW / 864.1850)

• Mayer's Hematoxylin Stain (FDA Code: HYL / 864.1850)

• Methenamine Silver Stain (FDA Code: HYZ / 864.1850)

• Methyl Green Stain (FDA Code: HZA / 864.1850)

• Microbial Detection Systems

• Microbiological Stain (FDA Code: JTS / 864.1850)

• Microscope Slides (FDA Code: KEW / 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

• Mucicarmine Stain (FDA Code: HZC / 864.1850)

• Nuclear Fast Red Stain (FDA Code: HZF / 864.1850)

• Oil Red O Stain (FDA Code: HZG / 864.1850)

• Papanicolau Stain (FDA Code: HZJ / 864.1850)

• pH Buffer (FDA Code: JCC / 864.4010)

• Probes (FDA Code: HXB / 888.4540)

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Progesterone Receptor Antibody Immunohistochemistry Assay (FDA Code: MXZ / 864.1860)

• Reagents

• Schiff Reagent Stain (FDA Code: HZT / 864.1850)

• Silver Carbonate Solution (FDA Code: KKP / 864.1850)

• Silver Nitrate (FDA Code: HZX / 864.1850)

• Sudan Black B Stain (FDA Code: HZZ / 864.1850)

• Trypsin (FDA Code: IBG / 864.4400)

Enzyme preparations are products that are used in the histopathology laboratory for the following purposes: