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Address: 4104 24th Street, Suite 183, San Francisco, California 94114, USA
www.wescomicroscopes.com |
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Phone: +1-(415)-826-5732
Year Established: 1962
Annual Revenues: < USD 1 Million
Quality: CE Certified
Products: Video Camera Adapters, USB Microscope Camera, High Resolution Microscope Video Cameras, Surgical Microscope Video Camera Adapters, Medical Imaging, Test Equipment & Measuring Devices, ...
Wesco (Western Scientific Co Inc) markets biological microscopes that include compound, stereo, measuring, metallurgical and digital imaging systems. Our product WS7 Embryo Transfer Microscope offers
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Address: 429 Rockaway Valley Road, Bld. No 12, Boonton Twp., New Jersey 07005, USA
www.euroimmunus.com |
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Phone: +1-(973)-402-6101
FDA Registration: 3007118747
Products: Fluorescence Microscope Aids, Diagnostic Aids, Allergy Testing, Automated Immunoassay Analyzers, Automated Slide Stainer (FDA Code:
KPA), Infectious Disease Serology Test, ...
Euroimmun Us Inc manufactures medical diagnostic products. Our medical products include fluorescence-labeled antibodies, controls for indirect immunofluorescence, and test systems or single slides for
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FDA Code / Regulation: KEI / 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:
Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.