Bionostics Inc.

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Web: http://www.bionostics.com
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Address: 7 Jackson Rd., Devens, Massachusetts 01434, USA
Phone: +1-(978)-772-7070 | Fax: +1-(978)-772-7072 | Map/Directions >>

Profile: Bionostics Inc. provides medical device manufacturers with services for the development, manufacturing and packaging of calibration & quality control liquids.

The company was founded in 1981.

FDA Registration Number: 1220649

13 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.

• Blood Collection Systems (FDA Code: JKA / 862.1675)

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

• Blood Gas Controls (FDA Code: JJS / 862.1660)

• Capillary Blood Collection Tubes (FDA Code: GIO / 864.6150)

A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.

• Clinical Tonometer (FDA Code: LCH / 862.1660)

• Diabetes Diagnostics Test Systems

• 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.

• Electrolyte Control (FDA Code: JJR / 862.1660)

• Hematocrit Control (FDA Code: GLK / 864.8625)

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

• Hematology Quality Control Mixture (FDA Code: JPK / 864.8625)

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

• pH Buffer (FDA Code: JCC / 864.4010)

• pH Buffer Calibration Solutions