Profile: Qiagen provides integrated solutions for life sciences. We offer products like animal & vertenary testing, biomedical research, drug development, genetic identics, forensics, biosecurity, water & environmental testing. Biosecurity is designed to provide the research tools you need for biosecurity and biodefense applications. Rapid response to potential threats and thorough preparedness to thwart plans of bio terrorism are paramount for public safety and international security. Our new epitect bisulfite kit delivers complete conversion and cleanup of DNA for methylation analysis in less than six hours. Our extensive range of cleanup kits set the standard for DNA purity, recovery and concentration.

FDA Registration Number: 3004013603
US Agent: Lindsey Howard / Qiagen Sciences Llc
Phone: +1-(240)-686-7826  Fax: +1-(240)-686-7827  E-Mail:

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• 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 Genetic Testing Instruments

• Automated Pipetter

• Benchtop Centrifuges

• Benchtop Microcentrifuges

• Blood Bank Test Kits

• Blood Cards

• Centrifuges

• Centrifuges, Personal Microcentrifuges

• 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).

• 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.

• Consolidated Workstations Instruments

• Controls

• Controls for Diagnostic Equipment

• Culture Plate

• Cytology Cervical Spatula (FDA Code: HHT / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Cytomegalovirus DNA Reagents (FDA Code: LSO / 866.3175) Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.

• Digital Microcentrifuges

• Digital Variable-Speed Microcentrifuges

• DNA Amplification For GC/CT Instruments

• DNA Sample Purification Kits

• DNA-Probe Test

• Dual Bank Vacuum Manifolds

• Electric Powered Vacuum Pumps

• Extraction Equipment

• General Nutrient Broth Culture Media (FDA Code: JSC / 866.2350) A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by their ability to promote or inhibit the growth of the test organism in the innoculated medium. Test results aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum. Tests results may also be used to monitor the effects of the administration of certain antimicrobial drugs.

• General Purpose Reagent (FDA Code: LDT)

• General Test Kits

• Genetic Testing Equipment

• Hepatitis B Viral DNA Detection (FDA Code: MKT)

• High Performance Microcentrifuges

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

• Human Papillomavirus DNA Detection Kit (FDA Code: MAQ)

• Laboratory Automation Systems

• Laboratory Centrifuges, Floor

• Liquid Ring and Dry Vacuum Pumps

• Microcentrifuges

• Microcentrifuges Non-Refrigerated

• MiniFuge Microcentrifuges

• Molecular Analyte Specific Reagents (ASR)

• Molecular Biology Buffers

• Molecular Biology, Reagents

• Multi-Analyte Controls Unassayed (FDA Code: OHQ / 862.1660) A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

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

• Neurology Instruments

• Personal Mini Microcentrifuges

• Phlebotomy Disposals

• Pipetting and Diluting Station (FDA Code: JQW / 862.2750) A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.

• Plate Sealing Films

• Protein Assay Kits