Profile: Sentinel CH. SRL concentrates on the development and production of diagnostic kits for use in medical analysis laboratories, hospitals, clinics & private healthcare structures. We offer products for cellular biology, clinical chemistry, coagulation, hematology and immunology laboratories. We are accredited with ISO 9001:2000 certification.

The company has revenues of USD 5-10 Million, has ~30 employees and is ISO 9001, CE certified.

FDA Registration Number: 9681753
US Agent: Fran White / Mdc Associates, Llc
Phone: +1-(978)-927-5011  Fax: +1-(978)-927-1308  E-Mail:

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• Agglutination Slides

• Alpha-1-Acid-Glycoprotein Antigen (FDA Code: LKL / 866.5420) Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

• Alpha-Fetoprotein Rapid Test Strip

• Ammonia Enzymatic Method Test (FDA Code: JIF / 862.1065) An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

• Amphetamine Test Strip

• Amylase Catalytic Method Test (FDA Code: JFJ / 862.1070) An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

• Anaerotestr Test Strips

• Anti-kappa Antiserum (FDA Code: DFH / 866.5550) An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

• 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.

• Bacteria Characterization Test

• Benzodiazepines Test Strip

• Blood Glucose Test Strips

• Blood Leak Test Strips

• C-Reactive Protein (CRP), FITC Conjugate (FDA Code: DCK / 866.5270) A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

• Carcinoembryonic Antigen Rapid Test Strip

• Ceruloplasmin Indirect Copper Assay (FDA Code: JFR / 866.5210) A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

• Cholesterol Test Strips

• Cholinesterase Colorimetry Test (FDA Code: DIH / 862.3240) A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

• Coagulometer Cuvette

• Coagulometer Stirring Bar

• Cocaine Test Strip

• Creatinine Enzymatic Method Test (FDA Code: JFY / 862.1225) A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

• Creatinine Test Strips

• Diabetes Test Strips

• Diagnostic Kits

• Dry Reagent Test Strips

• Electrophoresis Instrumentation (FDA Code: JZS / 866.4500) Immunoelectrophoresis equipment for clinical use with its electrical power supply is a device used for separating protein molecules. Immunoelectrophoresis is a procedure in which a complex protein mixture is placed in an agar gel and the various proteins are separated on the basis of their relative mobilities under the influence of an electric current. The separated proteins are then permitted to diffuse through the agar toward a multispecific antiserum, allowing precipitation and visualization of the separate complexes.

• Enzyme Immunoassay Test

• Fecal Occult Blood Test Strip

• Fertility Monitors, Pregnancy Test Kits

• Glutaraldehyde Test Strips

• Hcg Pregnancy Test Strip

• HDL/LDL Calibrator

• Hemolysis Reagent

• Home pregnancy test kits, Hcg

• Insulin Test Strip

• Iron Binding Capacity Bathophenanthroline (FDA Code: JQF / 862.1415) An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

• Iron Photometric Method (FDA Code: JIY / 862.1410) An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

• Lambda Antiserum (FDA Code: DEH / 866.5550)

• Lipase Photometric Enzymatic Lipase-Esterase Test (FDA Code: CHI / 862.1465) A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

• Lithium Spectrophotometry Porphyrin Assay (FDA Code: NDW / 862.3560) A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

• Menopause Test strip (Urine)

• Methadone Test Strip

• Methamphetamine Test Strip

• 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.)

• Multiparametric Calibrator

• Ovulation Test Strip (Urine)

• Peracetic Acid Test Strips

• PeriScreen Test Strips