Vision Instruments Ltd.

Address: 495 Blackburn Rd., Mount Waverley, Melbourne, Victoria, Australia
Phone: +61-(3)-921-1 74 | Map/Directions >>

Profile: Vision Instruments Ltd. offers tissue processors. Our products include analytic specific reagents, automated slide stainer, automated tissue processor, and general purpose reagents. We also provide hand-carried stretcher.

FDA Registration Number: 8020030
US Agent: Adam Blunier / Leica Microsystems, Inc.
Phone: +1-(847)-821-3462 E-Mail:

18 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:

• Anti-Ribosomal P Antibodies (FDA Code: MQA / 866.5100)

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

• Anti-RNP Antibody (FDA Code: LKO / 866.5100)

• Antigen And Control Extractable Antinuclear Antibody (FDA Code: LLL / 866.5100)

• 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.

• Clinical Sample Concentrator (FDA Code: JJH / 862.2310)

A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed.

• Control Antigen Antinuclear Antibody (FDA Code: LKJ / 866.5100)

• Enzyme Labeled Anti-DNA Antibody (FDA Code: LRM / 866.5100)

• Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 866.5100)

• 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.

• Femoral Leg Traction Splint

• General Purpose Reagent (FDA Code: LDT)

• Hand-Carried Stretcher (FDA Code: FPP / 880.6900)

A hand-carried stretcher is a device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which a patient can be carried.

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

• Microscope Stage (FDA Code: KEJ / 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:

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

• Traction Splint (FDA Code: HSP / 888.5890)

A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body.