Profile: BBI Diagnostics manufactures biological based materials. Our products are used in diagnostic tests, commercial bioproduction of therapeutic drugs and additional research applications. We focus on biotechnology, pharmaceutical and diagnostic industries. We also produce plasma-based therapeutic products, diagnostic products and reagents. We supply cell culture products, specialty plasmas, in vitro stabilizers and clinically annotated DNA, RNA, serum as well as tissue specimens.
The company has revenues of USD 5-10 Million and is ISO 9001, CE certified. NASDAQ:BBII (SEC Filings)
FDA Registration Number: 2022994
22 Products/Services (Click for related suppliers)
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| • 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. |
| • Blood Bank Test Kits |
| • Borrelia Serological Reagent (FDA Code: LSR / 866.3830) |
| • 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. |
| • Contract Manufacturing |
| • Controls |
| • Controls for Diagnostic Equipment |
| • Cytomegalovirus Virus IF Antibody Igm Test (FDA Code: LKQ / 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. |
| • Discrete Photometric Chemistry Analyzer (FDA Code: JJE / 862.2160) A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units. |
| • Durable Product Contract Manufacturing |
| • Enzyme Immunoassay Test |
| • Equipment Contract Research & Development |
| • Fluorometers (FDA Code: JZT / 866.4520) Immunofluorometer equipment for clinical use with its electrical power supply is a device used to measure the fluorescence of fluorochrome-labeled antigen-antibody complexes. The concentration of these complexes may be measured by means of reflected light. A beam of light is passed through a solution in which a fluorochrome has been selectively attached to serum protein antibody molecules in suspension. The amount of light emitted by the fluorochrome label is detected by a photodetector, which converts light energy into electrical energy. The amount of electrical energy registers on a readout system such as a digital voltmeter or a recording chart. This electrical readout is called the fluorescence value and is used to measure the concentration of antigen-antibody complexes. |
| • Immunoassays |
| • Infectious Disease Test Kits |
| • Multi Analyte Control (FDA Code: JJY / 862.1660) |
| • Photometer |
| • 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. |
| • Positive Control Serological Kit (FDA Code: MJX / 862.1660) |
| • Quality Control Kit for Blood Banking Reagents (FDA Code: KSF / 864.9650) A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking. |
| • Toxoplasma Gondii IF Antisera Test (FDA Code: LJK / 866.3780) |
| • Used Equipment Service |