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Profile: DRG International, Inc. is a multinational specialty medical equipment and diagnostics manufacturer & distributor. We offer products for enzyme immunoassays, rapid saliva & tumor tests, radio immunoassays & lab equipments. Our enzyme immunoassays include adrenocorticotropic hormone, alpha fetoprotein, anti-nuclear antibodies, atrial natriuretic polypeptide, acylation-stimulating protein, adiponectin rat elisa, neopterin elisa, norepinephrine and vanyl mandelic acid. We offer laboratory equipments such as check strips, microplate reader, incubator, photometer check set, rack tubes, sperm quality analyzer and strip reader.

The company was founded in 1970, has revenues of USD 10-25 Million, has ~100 employees and is ISO 9000, ISO 9001, CE certified.

FDA Registration Number: 2245285

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• 17-Hydroxyprogesterone Radioimmunoassay Test (FDA Code: JLX / 862.1395) A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.

• 2 Herpesvirus Hominis 1 Fluorescent Antisera (FDA Code: GQL / 866.3305)

• Acetylcholine Blocking And Non-Blocking Acetylcholine Receptor Autoantibodies (FDA Code: NST / 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).

• ACTH Radioimmunoassay Test (FDA Code: CKG / 862.1025) An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

• Adenovirus 1-33 CF Antigen (FDA Code: GOD / 866.3020) Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).

• Adrenocorticotropic Hormone

• Aldosterone Radioimmunoassay Test (FDA Code: CJM / 862.1045) An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.

• Alpha Fetoprotein (AFP)

• Alpha Fetoprotein Test Kit

• Alpha-1-B-Glycoprotein Antiserum Antigen Control (FDA Code: DEX / 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.

• Amphetamine Enzyme Immunoassay Test (FDA Code: DKZ / 862.3100) An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

• Amphetamine Thin Layer Chromatography (FDA Code: DIT / 862.3100)

• Amylase

• ANA (Antinuclear antibodies)

• Androstenedione Radioimmunoassay Test (FDA Code: CIZ / 862.1075) An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.

• Angiotensin II

• Angiotensin II EIA Kit

• Anti-acetylcholine Receptor Alpha Monoclonal Antibody

• Anti-Aldosterone

• Anti-Androstenedione

• Antigen And Control Extractable Antinuclear Antibody (FDA Code: LLL / 866.5100) An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

• Antineutrophil Cytoplasmic Antibodies (ANCA) Test System (FDA Code: MOB / 866.5660)

• Antisera, Control for Non-Treponemal Test (FDA Code: GMP / 866.3820)

• Antistreptolysin-Titer/Streptolysin O Reagent (FDA Code: GTQ / 866.3720)

• Apolipoproteins (FDA Code: MSJ / 862.1475) A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

• Aspergillus Spp CF Antigen (FDA Code: JWT / 866.3040)

• 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 Radioimmunoassay Systems (FDA Code: LCI / 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.

• Barbiturate Enzyme Immunoassay Test (FDA Code: DIS / 862.3150) A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

• Barbiturates ELISA Kits

• Benzodiazepine Enzyme Immunoassay Test (FDA Code: JXM / 862.3170) A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

• Benzodiazepines Test Strip

• Beta-2-Microglobulin Immunological Test System (FDA Code: JZG / 866.5630) Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

• Biopotential Amplifier and Signal Conditioner (FDA Code: DRR / 870.2050) A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin.

• Borrelia Serological Reagent (FDA Code: LSR / 866.3830)

• Brucella Spp Agglutination Antigen (FDA Code: GSO / 866.3085)

• C Peptides of Proinsulin Radioimmunoassay Test (FDA Code: JKD / 862.1135) A C-peptides of proinsulin test system is a device intended to measure C-peptides of proinsulin levels in serum, plasma, and urine. Measurements of C-peptides of proinsulin are used in the diagnosis and treatment of patients with abnormal insulin secretion, including diabetes mellitus.

• 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.

• C-Reactive Protein Test System (FDA Code: DCN / 866.5270)

• C. Diphtheriae Fluorescent Antiserum (FDA Code: GOS / 866.3140)

• Calcitonin Radioimmunoassay Test (FDA Code: JKR / 862.1140) A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

• Campylobacter Pylori (FDA Code: LYR / 866.3110)

• Candida Albicans ID Antigen (FDA Code: LHK / 866.3165)

• Cannabinoids Enzyme Immunoassay Test (FDA Code: LDJ / 862.3870) A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

• Capsid Epstein-Barr Virus Antigen (FDA Code: MCD / 866.3235) Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).

• Cardiac Panel

• Cardiovascular Surgical Instrument (FDA Code: DWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

• Catecholamines Chromatographic/Fluorometric Method Test (FDA Code: CHQ / 862.1165) A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma).

• Chlamydia Rapid Test

• Chlamydia Test Kits