Profile: Leica Microsystems GmbH is a designer and producer of high-tech precision optic systems for the analysis of microstructures. We specialize in the fields of microscopy, confocal laser scanning microscopy, microscope software, specimen preparation and medical equipment. We manufacture a broad range of products for numerous applications requiring microscopic imaging, measurement and analysis. We also offer system solutions in the areas of life science including biotechnology and medicine, as well as the science of raw materials & industrial quality assurance. The Leica DM1000 LED features long-life LED illumination that provides near daylight, bright illumination with constant color temperature and emits less heat. The LED also eliminates the need for lamp changes. It is ideal for all clinical laboratory applications, especially for cytology, hematology, and pathology. The Leica DM3000 microscope for pathology, cytology, and hematology features a motorized nose piece, condenser head, automated light intensity adjustment & optional foot pedal. This intuitive microscope improves cytology and pathology workflows. The motorized condenser head knows the correct position for each magnification. The Leica DM3000 automatically adjusts light intensity to each objective’s requirements, and stores previously used light values for each magnification.

The company was founded in 1997, has revenues of USD 25-50 Million, has ~20 employees and is CE certified.

FDA Registration Number: 8010478
US Agent: Adam Blunier / Leica Microsystems, Inc.
Phone: +1-(847)-821-3462  E-Mail:

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• Acid Containing Decalcifier Pathology Solution (FDA Code: KDX / 864.4010)

• Acid Containing Fixative (FDA Code: LDW / 864.4010)

• Advanced Ergonomic System Microscopes

• Alcohol Containing Fixative (FDA Code: LDZ / 864.4010)

• 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:

• Angiographic X-Ray System (FDA Code: IZI / 892.1600) An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Automated Genetic Testing Instruments

• Automated Intelligent Microscope

• Automated Microscope for Basic Life Science Research

• 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 Upright Microscope Systems

• Automatic Rotary Microtome (FDA Code: IDO / 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.

• Binocular and Trinocular Inverted Microscopes

• Bone Mallets (FDA Code: HXL / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Cameras

• Cameras, Video & Optical Systems

• Ceiling-Mounted Surgical Microscopes

• Cell Counter Instruments

• Clearing Agent (FDA Code: KEM / 864.4010)

• Clinical CH2 microscopes

• Clinical CX Microscopes

• Clinical Inverted Microscopes

• Clinical Microscopes

• Clinical Specular Microscopes (FDA Code: NQE / 886.1850) An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

• Colposcope and Accessories (FDA Code: HEX / 884.1630) A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.

• Consultants, Equipment Selection

• Coverslippers

• Cryostat Equipment

• Cryostat Microtome (FDA Code: IDP / 864.3010)

• Cryostat Microtome Blade Holders

• Cryostats

• Cytological Preservative (FDA Code: LEA / 864.4010)

• Cytology Equipment Processing & Embedding

• Cytology Equipment Stainers

• Dental Automatic Radiographic-Film Processor (FDA Code: EGY / 892.1900) An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.

• Diagnostic/Surgical Loupe (FDA Code: FSP / 878.4800)

• Digital Extraoral Source X-ray System (FDA Code: MUH / 872.1800) An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

• Digital Imaging Systems

• Digital Imaging, Microscopy

• Digital Microimaging Network Instruments

• Dye Powder Stain (FDA Code: LEF / 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.

• Electronic, Rotary Microtomes;

• Embedding Container (FDA Code: KER / 864.3010)

• Eosin Y Stain (FDA Code: HYB / 864.1850)

• Ergonomic System Microscope with Intelligent Automations

• Ergonomic System Microscopes

• Ergonomics Stereo Microscopes

• 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.

• Fixed Stage Microscopes