Bioclone Australia Pty Limited

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Contact: Mr. Graeme Davison - International & National Sales Manager
Web: http://www.bioclone.com.au
E-Mail:
Address: 71-73 Railway Parade, Marrickville, NSW 2204, Australia
Phone: (0)2 9517-1966, 800-251- | Fax: (0)2 9517-2990 | Map/Directions >>

Profile: Bioclone Australia Pty Limited specializes in the design and manufacture of high quality immunodiagnostic products for medical and research laboratory markets. Our focused activities include monoclonal antibodies, bulk reagents, contract development and contract manufacturing services. Our products include growth markers,allergy diagnostics, tests to monitor iron metabolism, neonatal screening, assays for TSH and IRT, reagents for cancer diagnosis and hepatitis tests.

The company was founded in 1981, has ~20 employees and is ISO 9001, CE certified.

30 Products/Services (Click for related suppliers)

• Allergy Test

• Allergy Testing

• 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:

• Anti-acetylcholine Receptor Alpha Monoclonal Antibody

• Chlamydia Group Enzyme Linked Immunoabsorbent Assay (FDA Code: LJC / 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).

• Durable Product Contract Manufacturing

• Elisa Allergy test Kit

• Ferritin (FDA Code: DBF / 866.5340)

A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

• Follicle Stimulating Hormone Radioimmunoassay (FDA Code: CGJ / 862.1300)

A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

• 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.

• Home Allergy 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.

• Human Growth Hormone Radioimmunoassay (FDA Code: CFL / 862.1370)

A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

• IgE Control (FDA Code: DGC / 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.

• Latex Allergy Test Kit

• Luteinizing Hormone Radioimmunoassay (FDA Code: CEP / 862.1485)

A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

• Monoclonal Antibody Test

• Polyclonal Antibody

• Polyclonal Antibody Goat Anti-HbsAg IgG

• Polyclonal Antibody Goat Anti-human IgG

• Polyclonal Antibody Goat Anti-mouse IgG

• Polyclonal Antibody Goat Anti-rabbit IgG

• Polyclonal Antibody Goat Anti-whole hCG

• Product Development, Allergy Test Strips

• Progesterone Radioimmunoassay Test (FDA Code: JLS / 862.1620)

A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

• Prolactin Radioimmunoassay (FDA Code: CFT / 862.1625)

A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

• Protein-Bound Iodine Wet Ash Method (FDA Code: JIJ / 862.1640)

A protein-bound iodine test system is a device intended to measure protein-bound iodine in serum. Measurements of protein-bound iodine obtained by this device are used in the diagnosis and treatment of thyroid disorders.

• Reagent Contract Manufacturing

• 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.

• 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.