Brahms Diagnostica GmbH

Click Here To EMAIL INQUIRY
Web: http://www.brahms.de
E-Mail:
Address: Komturstr. 19-20, Berlin 12099, Germany
Phone: +49-(30)-75012-5 | Fax: +49-(30)-75012802 | Map/Directions >>

Profile: Brahms Diagnostica GmbH develops and produces diagnostic test procedures to improve diagnosis, and thereby the treatment of life-threatening illnesses. We are engaged in the production & marketing of medical test kits. Our products include intensive care & emergency medicine, prenatal screening, neopterin radio immuno assay, and MR-proANp time resolved amplified cryptate emission. Our activities primarily focus on sepsis and infection, tumors, fertility, prenatal screening & thyroid diseases. Our assays are available in different formats, such as the fully automated Kryptor version with Trace technology, or using tried and trusted conventional technologies such as radioimmunoassay, luminescence assay or enzyme immunoassay.

FDA Registration Number: 3003561301
US Agent: Jeffrey J. Fisher / Fisher Diagnostics, A Division Of Fisher Scientific Co. Llc
Phone: +1-(540)-869-3200 E-Mail:

9 Products/Services (Click for related suppliers)

• ACTH Radioimmunoassay Test (FDA Code: CKG / 862.1025)

An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

• 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.

• Peroxidase Conjucated IgG (FDA Code: DAA / 866.5510)

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

• Secondary Calibrator (FDA Code: JIT / 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.)

• Sepsis Inflammatory Response Marker Antigen (FDA Code: NTM / 866.3210)

An endotoxin assay is a device that uses serological techniques in whole blood. The device is intended for use in conjunction with other laboratory findings and clinical assessment of the patient to aid in the risk assessment of critically ill patients for progression to severe sepsis.

• Thyroglobulin Autoantibody Immunochemical (FDA Code: JNL / 866.5870)

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

• Thyroglobulin Test System (FDA Code: MSW / 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.

• Thyroid Autoantibody Test System (FDA Code: JZO / 866.5870)

• 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.