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Bacterial Sialidase Vaginal Test Suppliers

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Gryphus Diagnostics, L.L.C. | Address: 2280 Sutherland Avenue, Suite 101, Knoxville, Tennessee 37919-2326, USA USA
www.gryphus.com | Send Inquiry | Phone: +1-(865)-251-0101, 800- 924-419
FDA Registration: 3006546675  Year Established: 1998
Products: Periodontal Probes, Influenza Virus Antisera (FDA Code: GNS), Candida Albicans ID Antigen (FDA Code: LHK), Trichomonas Vaginalis Dna Probe (FDA Code: MJK), Bacterial Sialidase Vaginal Test (FDA Code: MXB), Diagnostic Rapid Test Kits, ...
Gryphus Diagnostics, LLC specializes in development and manufacture of rapid detection systems. Our products is BVblue® rapid tests for bacterial vaginosis. Our BVblue® is for use in the clini more...
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FDA Code / Regulation: MXB / 866.2660

A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.

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