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Address: 1910 Innovation Park Dr., Tucson, Arizona 85755, USA
www.ventanamed.com |
Send Inquiry |
Phone: +1-(520)-887-2155, 800-227-2155
FDA Registration: 2028492 Year Established: 1991
Employee Count: ~950
Products: Probes (FDA Code:
HXB), Trabeculotomy Probes, Mini-Lacrimal Probes, Laser Surgical Systems, Laser Illumination Probes, Pigtail Curved Blunt Probes, Surgical Instruments, Bone Awls and Probes, ...
Ventana Medical Systems, Inc. deals with diagnostic instruments and reagent systems for use in slide-based diagnosis of cancer and infectious disease. Our products are found in hospital-based histolog
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Address: 4600 Norris Canyon Road, San Ramon, California 94583-1320, USA
www.biogenex.com |
Send Inquiry |
Phone: +1-(925)-275-0550, 800-421-4149
FDA Registration: 3008776165 Year Established: 1981
Annual Revenues: USD 10-25 Million
Employee Count: ~120
Quality: ISO 9001, CE Certified
Products: Probes (FDA Code:
HXB), Microbial Detection Systems, Imaging Systems, Reagents, Molecular Diagnostic Services, Methyl Green Stain (FDA Code:
HZA), ...
Biogenex Laboratories specializes in the field of molecular diagnostics. We support cellular & molecular pathology laboratories with a range of reagents, detection kits, antibodies, probes, special st
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FDA Code / Regulation: KKP / 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.
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. These devices are also 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.