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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• Potassium Ion Specific Electrode (FDA Code: CEM / 862.1600) A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

• 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.)

• Prothrombin Time Test (FDA Code: GJS / 864.7750) A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

• 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).

• Russel Viper Venom Reagent (FDA Code: GIR / 864.8950) Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.

• Sodium Ion Specific Electrode (FDA Code: JGS / 862.1665) A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

• Systemic Lupus Erythematosus Test (FDA Code: DHC / 866.5820) A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).

• Thrombin Time Test (FDA Code: GJA / 864.7875) A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.

• Toxicology Lithium Flame Photometer

• Transcutaneous BP Oxyhemoglobin Concentration Analyzer

• 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.

• Whole Blood Coagulation Analyzer

• Whole Blood Oximeter (FDA Code: GLY / 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.