More Diagnostics, Inc.

Click Here To EMAIL INQUIRY
Contact: Mr. Peter Bennett - International & National Sales Manager
Web: http://www.morediagnostics.com
E-Mail:
Address: PO Box 6714, Los Osos, California 93412, USA
Phone: +1-(805)-528-6005, 800-758-0978 | Fax: +1-(805)-528-3532 | Map/Directions >>

Profile: More Diagnostics, Inc. is a manufacturer and distributor of clinical diagnostic quality controls for cardiac markers, cyclosporine C2, mycophenolic acid, TAC/CsA and RAP/TAC/CsA, featuring reliable specialty immunosuppressant control. The controls are prepared from stabilized human serum spiked with analytes from purified human heart.

The company was founded in 1993, has revenues of USD 1-5 Million, has ~10 employees and is ISO 9001, CE certified.

FDA Registration Number: 2085085

12 Products/Services (Click for related suppliers)

• 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.

• Cardiac Markers

• Cyclosporine (FDA Code: MKW / 862.1235)

A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine.

• Cyclosporine and Metabolites Serum Assay (FDA Code: MAR / 862.1235)

• Cyclosporine High Performance Liquid Chromatography (FDA Code: MGS / 862.1235)

• Drug Mixture Control Materials (FDA Code: DIF / 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.

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

• Enzyme Controls (FDA Code: JJT / 862.1660)

• Fibrinogen and Fibrin Split Products (FDA Code: DAP / 864.7320)

A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).

• Fluorescence Polarization Immunoassay for Cyclosporine (FDA Code: MGU / 862.1235)

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

• Primary Calibrator (FDA Code: JIS / 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.)