Profile: Instrumentation Laboratory (IL) manufactures and supplies critical care diagnostic & hemostasis instruments. We offer products like haemostatisis diagnostics, critical care diagnostics & acc trak. In addition to features such as its self-contained cartridge system and comprehensive menu options, the GEM Premier 3000 now offers intelligent quality management, an internal, automated program that performs continuous quality management. Our ACL™ line employs advanced optical technology & sets a standard for precision and operational simplicity. Our HemosIL™ line of reagents offers flexibility, accuracy and dependability. We are proud to offer quality control products to assist you with exceptional quality control management in your laboratory. This service is offered to all customers using IL control products.

The company was founded in 1959, has revenues of USD 50-100 Million, has ~300 employees.

FDA Registration Number: 1217183

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• Abnormal Plasma Control (FDA Code: GGC / 864.5425) A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

• Activated Partial Thromboplastin (FDA Code: GFO / 864.7925) A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

• Antithrombin III Quantitation Test (FDA Code: JBQ / 864.7060) An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

• 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 Coagulation Analyzer (FDA Code: GKP / 864.5400) A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

• Automated Coagulation Instrument (FDA Code: GKP / 864.5400)

• Automated Coagulation Timer

• Automated Hematocrit Instrument (FDA Code: GKF / 864.5600) An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

• 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.

• Blood Clot Coagulation Analyzer (FDA Code: GKP / 864.5400)

• Blood Gas Analyzers

• 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.

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

• Blood Gas/pH analyzer

• Blood Oxyhemoglobin Concentration Analyzer

• Blood Phase Oxyhemoglobin Concentration Analyzer (Non-Indwelling, Oxygen)

• Calcium Ion Specific Electrode (FDA Code: JFP / 862.1145) A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

• 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.

• Carboxyhemoglobin Assay (FDA Code: GHS / 864.7425) A carboxyhemoglobin assay is a device used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning. This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, and gasometry.

• Chloride Ion Specific Electrode (FDA Code: CGZ / 862.1170) A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

• Clinical Colorimeter (FDA Code: JJQ / 862.2300) A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.

• Co-Oximeter

• Coagulation Analyzer with Timer (FDA Code: GKP / 864.5400)

• Coagulation Analyzers (FDA Code: GKP / 864.5400)

• Coagulation Factor Deficient Plasma (FDA Code: GJT / 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).

• Discrete Photometric Chemistry Analyzer (FDA Code: JJE / 862.2160) A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

• Electrolyte Chemistry Analyzer

• Factor XIII A (FDA Code: DBT / 866.5330) A factor XIII, A, S, immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the factor XIII (a bloodclotting factor), in platelets (A) or serum (S). Measurements of factor XIII, A, S, aid in the diagnosis and treatment of certain bleeding disorders resulting from a deficiency of this factor.

• 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).

• Fibrinogen Determination Standard and Control (FDA Code: GFK / 864.7340) A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

• Fibrinogen Determination System Test (FDA Code: KQJ / 864.7340)

• Fibrinogen Standard (FDA Code: GFX / 864.7340)

• Fibrinogen Test (FDA Code: GIS / 864.7340)

• Fluorometric Calcium (FDA Code: JFO / 862.1145)

• 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 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).

• Heparin Assay (FDA Code: KFF / 864.7525) A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

• Immunological Anticardiolipin Test System (FDA Code: MID / 866.5660) A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

• Indwelling Blood Phase Oxyhemoglobin Concentration Analyzer (FDA Code: JED / 868.1120) An indwelling blood oxyhemoglobin concentration analyzer is a photoelectric device used to measure, in vivo, the oxygen-carrying capacity of hemoglobin in blood to aid in determining the patient's physiological status.

• Ion Selective Electrode (FDA Code: JJP / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• Lactic Acid Enzymatic Method (FDA Code: KHP / 862.1450) A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

• 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.)

• Multipurpose System for Invitro Coagulation Studies (FDA Code: JPA / 864.5425)

• Non-Indw Blood Phase Carboxyhemoglobin Gas Analyzer

• Normal And Abnormal Hemoglobin Standards And Controls (FDA Code: GFS / 864.8625)

• Normal Control Plasma (FDA Code: GIZ / 864.5425)

• Oxyhemoglobin (FDA Code: GGZ / 864.7500) A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

• Partial Thromboplastin Test Time (FDA Code: GGW / 864.7925)

• Plasma Coagulation Control (FDA Code: GGN / 864.5425)