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Address: 10210 Genetic Center Drive, San Diego, California 92121, USA
www.gen-probe.com |
Send Inquiry |
Phone: +1-(888)-484-4747
FDA Registration: 2024800 Year Established: 1983
Annual Revenues: USD 100-500 Million
Employee Count: ~70
Quality: ISO 9001, CE Certified
Products: Swabs, Laboratory Automation Systems, HIV Screening - NAT, Chlamydia Test Kits, Preps & Swabs, Cotton Swabs, ...
Gen-probe Incorporated specializes in nucleic acid diagnostics. We are an ISO 9001, CE MARK certified company. We offer products like clinical diagnostics, blood screening, nucleon DNA extraction & ge
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Address: Atlantic Research & Development Park, Princeton, New Jersey 11791, USA
www.atfirstdiagnostic.com |
Send Inquiry |
Phone: +1-(516)-776-9262
Products: Urinalysis Strips, Ovulation (Luteinizing Hormone) Test Kits, Gonorrhea Test Kits, Chlamydia and Gonorrhea Tests, Rapid H. pylori Antibody (IgM/IgG/IgA) Test kits, Hepatitis Disease Surface Antigen (HBsAg) Test Kits, ...
AT First Diagnostic Ltd specializes in the development and marketing of quality rapid diagnostics. We are accredited with ISO 9001 certification. We use a new patent pending lateral flow technology fo
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Address: 920-A Calle Negocio, San Clemente, California 92673, USA
www.americanqualex.com |
Send Inquiry |
Phone: +1-(949)-492-8298, 800-772-1776
Year Established: 1981
Annual Revenues: < USD 1 Million
Employee Count: ~10
Products: Flow Cytometry, Reagents, Monoclonal Antibody Test, Polyclonal Antibody, Peptides, Neisseria Gonorrhoeae Biochemical Reagent Test (FDA Code:
LTS), ...
American Qualex, Inc. is a diagnostic assay development company serving immunology and molecular biology. We manufacture various products used in immunology and molecular biology applications. We prod
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Address: 3651 Clipper Mill Road, Baltimore, Maryland 21211-1991, USA
www.alphabiosciences.com |
Send Inquiry |
Phone: +1-(410)-882-7646, 877-825-7428
FDA Registration: 1125797 Year Established: 2000
Annual Revenues: < USD 1 Million
Employee Count: ~10
Products: Plant Tissue Culture Media, Amino Acid Assay Culture Media (FDA Code:
JRZ), Enriched Culture Media (FDA Code:
KZI), Neisseria Gonorrhoeae Biochemical Reagent Test (FDA Code:
LTS), Non-Selective and Differential Culture Media (FDA Code:
JSH), Non-Selective and Non-Differential Culture Media (FDA Code:
JSG), ...
Alpha Biosciences, Inc. is a provider of differential culture media. We specialize in the production of classical and custom culture media. We manufacture bacterial and fungal dehydrated culture media
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FDA Code / Regulation: LTS / 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.