Biocare Medical, LLC

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Web: http://www.biocare.net
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Address: 4040 Pike Lane, Concord, California 94520, USA
Phone: +1-(800)-799-9499 | Fax: +1-(925)-603-8080 | Map/Directions >>

Profile: Biocare Medical manufactures & supplies immunostaning systems, histopathology, monoclonal and polyclonal antibodies. We offer androgen receptor, calcitonin, calponin and calretinin.

FDA Registration Number: 3004140393

9 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:

• 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.

• General Medical Equipment

• General Purpose Reagent (FDA Code: LDT)

• Hematoxylin Stain (FDA Code: HYJ / 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.

• Hematoxylin Stain Solution with Phosphotungstic Acid

• Immunohistochemistry Reagents And Kits (FDA Code: NJT / 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.

• 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.

• Molecular Analyte Specific Reagents (ASR)