Global Instrumentation Corp.

Click Here To EMAIL INQUIRY
Contact: Bo-Yi Chen
Web: http://www.gicmd.com
E-Mail:

Address: 14 F., No. 186, Jian-Yi Road, Chung-Ho, Taipei 235, Taiwan
Phone: +886-(2)-8227 1666 | Fax: +886-(2)-8227 2727 | Map/Directions >>

Profile: Global Instrumentation Corp. provides manufacturing solutions to medical device & biomedical industries. We offer services in components procurement, printed circuit board assembly, product design & manufacturing, electronic and mechanical sub-assembly, and complete manufacturing services.

The company is ISO 9002, 13488 certified.

FDA Registration Number: 9710595
US Agent: Chuang-wei Chiu
Phone: +1-(509)-432-3420 E-Mail:

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.

• Automated Hemoglobin System (FDA Code: GKR / 864.5620)

An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

• Biomedical Devices

• Blood Gas and Ph Electrode Measurement (FDA Code: CHL / 862.1120)

A blood gases (PCO2, PO2) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

• Carbon-Monoxide Oxyhemoglobin/Carboxyhemoglobin Curve Test (FDA Code: JKS / 862.3220)

A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.

• General Medical Device

• Glucose Oxidase, Glucose (FDA Code: CGA / 862.1345)

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

• Hematocrit Measuring Device (FDA Code: JPI / 864.6400)

A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.

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

• 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.)

• Over-The-Counter Blood Glucose Test System (FDA Code: NBW / 862.1345)

• Turn-Key Medical Device Manufacturing