Biotest AG

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Web: http://www.biotest.de
E-Mail:
Address: Landsteiner Str. 5, Dreieich 63303, Germany
Phone: +49-(6903)-801 -0 | Fax: +49-(6903)-801- 150 | Map/Directions >>

Profile: Biotest AG specializes in immunology and hematology. Our product area includes pharmaceuticals and diagnostics. Our pharmaceuticals include plasma proteins and bio therapeutics. Our immunoglobins include intrarect, intraglobin F, pentaglobin, cytotect CP, hypatect CP and varitect CP. Our bio therapeutics include BT 061, BT062 and BT 063. Our medical diagnostics include transfusion, transplantation and infectious diseases. Our microbiological tests & systems include hygine monitoring, particle counting and molecular microbiology.

FDA Registration Number: 9610824
US Agent: David Bhend / Bio-rad Laboratories
Phone: +1-(425)-881-8300 Fax: +1-(425)-498-1651 E-Mail:

11 Products/Services (Click for related suppliers)

• Automated Blood Grouping and Antibody Test System (FDA Code: KSZ / 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.

• Epstein-Barr Virus (FDA Code: LSE / 866.3235)

Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).

• Hla-dqb Typing Kit (FDA Code: MVS / 866.5660)

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

• Invitro Diagnostic Potentiating Media (FDA Code: KSG / 864.9600)

Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.

• Leukocyte Typing Test (FDA Code: LGO / 864.7675)

A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.

• Non-diagnostic for HLA Quantitative Test (FDA Code: MZH)

• Non-Diagnostic Qualitative Test For Hla (FDA Code: MZI)

• Ophthalmology, Surgical Instrument Trays

• 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.

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Whole Human Serum (FDA Code: DGR / 866.5700)

A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.