Qualigen Inc.

Address: 2042 Corte Del Nogal, Carlsbad, California 92011, USA
Phone: +1-(760)-918-9165, 877-709-2169 | Fax: +1-(760)-918-9127 | Map/Directions >>

Profile: Qualigen, Inc. fabricates and markets the FastPack® System, which is a fully automated blood testing system. Our products include fastpack® IP system, TSH, Free T4, hcG, Total PSA, and Testo. The Qualigen FastPack ® IP system is the only available quantitative immunoassay analyzer featuring one-touch operation in delivering values for Thyroid Stimulating Hormone (TSH), Free Thyroxine (fT4), Human Chorionic Gonadotropin (hCG), Prostate Specific Antigen (PSA) free PSA and Testosterone. The system is simple, compact and provides laboratory accuracy in minutes. The FastPack® IP Testo Immunoassay is a chemiluminescent immunoassay for the in-vitro quantitative determination of total testosterone in human serum.

FDA Registration Number: 2032087

21 Products/Services (Click for related suppliers)  
• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 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.
• Automated Homogeneous Liposome Immunoassay Systems
• Automated Immunoassay Systems
• 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.
• Customized Immunoassay Systems
• Free Thyroxine Radioimmunoassay (FDA Code: CEC / 862.1695)
A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
• Human Chorionic Gonadotropin (hCG) Enzyme Immunoassay Test Kit
• Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI / 862.1155)
A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.
• Immunoassay Systems
• Multi Analyte Mixture - Calibrator (FDA Code: JIX / 862.1150)
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)
• Multiple Immunoassay Systems
• Prostate Specific Antigen Test (FDA Code: MTG)
• Prostate Specific Antigen Testing kit
• Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ / 866.6010)
A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
• Secondary Calibrator (FDA Code: JIT / 862.1150)
• Sensitive Immunoassay Systems
• Substrates For Immunoassay Systems
• Testosterone Radioimmunoassay Test Kits
• Testosterones and Dihydrotestosterone Radioimmunoassay (FDA Code: CDZ / 862.1680)
A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
• Thyroid Stimulating Hormone (TSH) EIA Test Kit
• Thyroid Stimulating Hormone Radioimmunoassay (FDA Code: JLW / 862.1690)
A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

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