Axis-Shield Diagnostics, Ltd.

Contact: Claire Dora
Web: http://www.axis-shield.com
Address: The Technology Park, Dundee, Scotland DD2 1XA, United Kingdom
Phone: +44-(1382)-422000 | Map/Directions >>

Profile: Axis-Shield Diagnostics, Ltd. focuses on the development and manufacture of in vitro diagnostic tests for use in clinical laboratories and at the point of care. We specialize in the supply of point of care diagnostic products. Our product range includes HbA1c, U-albumin, CRP, D-Dimer and specific tests. The Afinion CRP test is a point of care assay to indicate bacterial or viral cause of infection. With a total assay time of only 4 minutes, the CRP test result can support the clinical diagnosis of an inflammation. The NycoCard system comprises four selected PoC tests that include CRP, HbA1c, D-Dimer and U-Albumin. It can all be analyzed on the same instrument-the NycoCard reader II. Point of care has a range of documented PT-INR tests for use in the control of anticoagulation therapy. APTT-test is available for screening of the intrinsic coagulation system and facilitating the control of heparin therapy. The tests can be used in a point of care setting on Thrombotrack instruments or adapted to large coagulation analyzers for clinical laboratories. The Nycotest PT-INR is a reagent used for screening of the extrinsic coagulation system with sensitivity in the normal range. It is used for control of oral anticoagulation therapy.

FDA Registration Number: 8032314
US Agent: Leanne Kiviharju / Abbott
Phone: +1-(858)-805-2227 Fax: +1-(858)-281-8546 E-Mail:

18 Products/Services (Click for related suppliers)

• Anti-Cyclic Citrullinated Peptide (Ccp) Antibodies (FDA Code: NHX / 866.5775)

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

• 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.

• Beta-2-Microglobulin Immunological Test System (FDA Code: JZG / 866.5630)

Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

• Drug Specific Calibrator (FDA Code: DLJ / 862.3200)

A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also 862.2 in this part.)

• Drug Specific Control Test (FDA Code: LAS / 862.3280)

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

• Glycosylated Hemoglobin Assay Test (FDA Code: LCP / 864.7470)

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

• Low Density Lipoprotein (FDA Code: DFC / 866.5600)

A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

• Multi Analyte Control (FDA Code: JJY / 862.1660)

• 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.)

• Natriuretic Peptide Test (FDA Code: NBC / 862.1117)

The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

• Primary Calibrator (FDA Code: JIS / 862.1150)

• Qualitative and Quantitative Factor Deficiency Test (FDA Code: GGP / 864.7290)

A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).

• Secondary Calibrator (FDA Code: JIT / 862.1150)

• Sirolimus Test System (FDA Code: NRP / 862.3840)

A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.

• 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 Autoantibody Test System (FDA Code: JZO / 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.

• Urinary Homocystine Test System (FDA Code: LPS / 862.1377)

A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.

• Vitamin B12 Radioimmunoassay (FDA Code: CDD / 862.1810)

A vitamin B12test system is a device intended to measure vitamin B12in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.