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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• Fluorescence Laboratory Microscope

• Forceps (FDA Code: HTD / 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.

• Forensic Comparison Microscopes

• Formaldehyde (FDA Code: IGG / 864.4010)

• Formalin Containing Fixative (FDA Code: LDY / 864.4010)

• Formulations Paraffin (FDA Code: KEO / 864.4010)

• Fully Automated Inverted Research Microscopes

• Functional, Micro Recording Systems

• Gearless Rotary Microtome

• Gelatin for Specimen Adhesion (FDA Code: IFZ / 864.4010)

• General & Plastic Surgery Surgical Microscope (FDA Code: FSO / 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.

• General Medical Supplies

• General Purpose Reagent (FDA Code: LDT)

• Harris's Hematoxylin Stain (FDA Code: HYK / 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.

• Headmounted Microscopes

• Hematology Slide Stainer Instruments

• Hematoxylin Stain (FDA Code: HYJ / 864.1850)

• Hemostats (FDA Code: HRQ / 878.4800)

• High Resolution Digital Monochrome Cameras

• Histology and Pathology, Vibration Microtomes

• Histology Tissue Processors

• Image Capture Systems

• 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.

• Integrated Imaging Systems

• Integrated Standalone Digital Camera for Stereo Microscopes

• Inverted Laboratory Microscope with LED Illuminations

• Lab Automation Systems

• Laser-Based Point Scanning Confocal Microscopes

• Light Microscope (FDA Code: IBJ / 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:

• Low Power Binocular Loupe (FDA Code: HJH / 886.5120) A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.

• Manual Forensic Comparison Macroscopes

• Manual Inverted Microscopes

• Manual Osteotome (FDA Code: GFI / 878.4800)

• Manual Stereomicroscopes

• Microscope Cameras

• 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)

• Microscope Slides (FDA Code: KEW / 864.3010)

• Microscope Stage (FDA Code: KEJ / 864.3600)

• Microscope Television Monitor

• Microscopes

• Microscopes

• Microscopes & Telescopes

• Microscopes, Digital Image Capture Systems

• Microsection Sealing Device (FDA Code: KIM / 864.3400) A device for sealing microsections is an automated instrument used to seal stained cells and microsections for histological and cytological examination.

• Microtome Accessories (FDA Code: IDL / 864.3010)

• Microtome Equipment

• Microwave Tissue Processors

• Miscellaneous Accessories

• Motorized Forensic Comparison Macroscopes