Profile: 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 & genetic disease testing.We produce and commercialize DNA probe technologies for diagnosing sexually transmitted diseases & microbial infectious diseases. Our Gen-Probe GASDirect™ test for group A streptococcus is a DNA probe assay, which uses nucleic acid hybridization for the qualitative detection of group A streptococcal RNA directly from throat swabs with high sensitivity and specificity. We supply products all over the world.

The company was founded in 1983, has revenues of USD 100-500 Million, has ~70 employees and is ISO 9001, CE certified. NASDAQ:GPRO (SEC Filings)

FDA Registration Number: 2024800

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• Aerobic Transport System (FDA Code: JTW / 866.2900) A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

• 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:

• Automated Bloodborne Pathogen Test Equipment (FDA Code: MZA)

• Bacterial Diagnostic Test

• Blastomyces Dermatitidis EIA (FDA Code: MJL / 866.3060)

• Blood Bank Software (FDA Code: MMH / 864.9175) An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.

• Campylobacter Spp. (FDA Code: LQP / 866.3110)

• Campylobacter Spp. Dna-Reagents (FDA Code: LQO / 866.3110)

• Chlamydia DNA Reagents (FDA Code: LSK / 866.3120) Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

• Chlamydia Test Kits

• Chlamydia Trachomatis (FDA Code: MGM / 866.3120)

• Chlamydia trachomatis IgA ELISA Kit

• Chlamydia trachomatis IgG ELISA Kit

• Chlamydia Trachomatis IgG Kit

• Chlamydia trachomatis IgM ELISA Kit

• Chlamydia Trachomatis Real Time PCR Kit

• Clinical Colorimeter (FDA Code: JJQ / 862.2300) A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.

• Clostridium Difficile Toxin Reagent (FDA Code: LLH / 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.

• Coccidioides Immitis Reagents Dna-Probe (FDA Code: MDF / 866.3135)

• Cotton Swabs

• Cryptococcal Reagents Dna-Probe (FDA Code: MDE / 866.3165)

• Culture Tubes

• Detection And Identification Nucleic Acid Or Antigen 2009 H1n1 Influenza Virus (Swine Origin) (FDA Code: OQW / 866.3332)

• Direct Tube Sampling (DTS) Systems

• DNA Amplification For GC/CT Instruments

• Dna-Probe - Blastomyces Dermatitidis (FDA Code: MDC / 866.3060)

• Haemophilus Spp. Dna-Probe (FDA Code: MCC / 866.3300)

• Hemophilus Spp Fluorescent Antisera (FDA Code: GRO / 866.3300)

• Hinged Culture Tube Storage boxes

• Histoplasma Capsulatum Reagent (FDA Code: MBT / 866.3320)

• HIV Screening - NAT

• Human Metapneumovirus (Hmpv) Rna Assay System (FDA Code: OEM / 866.3980)

• Hybridization And/Or Nucleic Acid Amplification Assay For Detection Of Hepatitis C Rna, Hepatitis C Virus (FDA Code: MZP)

• Infectious Disease Identification Test Kits

• Infectious Disease Screening, HIV Screening - NAT

• Lab Automation Systems

• Laboratory Automation Systems

• Legionella DNA Reagents (FDA Code: LQH / 866.3300)

• Luminometer

• Microbiological Automated System

• Microbiology Identification Instruments

• Microbiology Identification Test Kits

• Microorganism Differentiation Strip and Reagent Disc (FDA Code: JTO / 866.2660)

• Molecular Biology, Reagents

• Mycobacteria Identification Kit (FDA Code: JSY / 866.2660)

• Mycobacterium Spp. Dna-Reagents (FDA Code: LQF / 866.3370)

• Mycobacterium Tuberculosis Complex Nucleic Acid Amplification System (FDA Code: MWA / 866.3372)

• Mycoplasma Spp. DNA-Reagents (FDA Code: LQG / 866.3375)

• Neisseria DNA Reagents (FDA Code: LSL / 866.3390)

• Neisseria Gonorrhoeae Biochemical Reagent Test (FDA Code: LTS / 866.2660)