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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• Motorized Forensic Comparison Microscopes

• Motorized Rotary Microtomes

• Multi-purpose Sliding Microtomes

• Neurological Camera Systems, Endoscopy Recording Systems

• Neurology Instruments

• Neurosurgical Surgical Microscope

• Neutral Buffered Formalin (FDA Code: IFP / 864.4010)

• Non-Sterile Specimen Container (FDA Code: NNI / 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.

• Oil Soluble Mounting Media (FDA Code: KEP / 864.4010)

• One-Piece Scalpel (FDA Code: GDX / 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.

• Operating Microscopes

• Ophthalmic AC-Powered Operating Microscope and Accessories (FDA Code: HRM / 878.4700) A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

• Optical Laboratory Microscope

• Orange G Stain (FDA Code: HZH / 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.

• OSHA Compliance Training

• Papanicolau Stain (FDA Code: HZJ / 864.1850)

• Paraffin Dispenser (FDA Code: IDW / 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.

• Paraffin Melting Pot (FDA Code: IDS / 864.3010)

• Pathology Tissue Flotation Bath (FDA Code: IDY / 864.3010)

• Polycut Series Sliding Microtome

• Powered Heating Unit (FDA Code: IRQ / 890.5950) A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.

• Powered Saw and Accessories (FDA Code: HAB / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• Powered Surgical Laser Instrument (FDA Code: GEX / 878.4810) (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.

• Printers & Labels

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

• Protective Apron (FDA Code: IWO / 892.6500) A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

• Radial Microtomes Sliding Microtomes

• Radiographic Film Illuminator (FDA Code: IXC / 892.1890) A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.

• Radiological Digital Image Communication System (FDA Code: LMD / 892.2020) A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol.

• Radiological Digital Image Storage Device (FDA Code: LMB / 892.2010) A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.

• Radiological Image Processing System (FDA Code: LLZ / 892.2050) A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

• Recording Systems

• Richardson Glycol Fixative (FDA Code: IFJ / 864.4010)

• Rotary and Sliding Microtomes

• Rotary Microtomes (FDA Code: IDO / 864.3010)

• Scalpel Blade (FDA Code: GES / 878.4800)

• Scalpel Handle (FDA Code: GDZ / 878.4800)

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

• Scientific Sliding Microtomes

• Semi-enclosed Tissue Processors

• semiautomated Specular Microscopes

• Slide Scanners

• Sliding Microtome Accessories

• Sliding Microtome Aids

• Sliding Microtomes (FDA Code: KFL / 864.3010)

• Software Programs

• Stainers

• Steam Sterilizers (FDA Code: FLE / 880.6880) A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

• Stereozoom Fluorescent Microscopes

• Surgical Knife (FDA Code: EMF / 878.4800)