Acon Biotech (Hangzhou) Co., Ltd.

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Web: http://www.aconlab.com.cn
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Address: 10125 Mesa Rim Road., San Diego 92121, China
Phone: +1-(858)-875-8000 | Fax: +1-(858)-200-0729 | Map/Directions >>

Profile: Acon Biotech (Hangzhou) Co., Ltd. provides a broad range of rapid diagnostic and healthcare products. We offer diabetes care, immunoassay, and clinical chemistry, such as urinalysis, urine analyzer, urinalysis home test, breath & saliva alcohol test products. Our Mission® Xpert urinalysis reagent strips are constructed with laminated mesh overlay, ASC resistance, analytical sensitivity, and canisters, and prevent false results. The breath alcohol detector is for detection of the presence of alcohol in the exhaled breath, and provides relative blood alcohol concentration rate. We also provide Foresight® HBsAg, HBsAb, HBeAg, HBeAb, and HBcAb EIA test kits. Our HBV EIA test kits are enzyme immunoassay for the detection of HBsAg, HBsAb, HBeAg, HBeAb, or HBcAb. They are intended as a screening tool for previous exposure to the Hepatitis B virus, follow-up of infected individuals, monitoring after vaccination or susceptibility to infection, and determination of need for vaccination.

FDA Registration Number: 9615507
US Agent: N/a / N/a

38 Products/Services (Click for related suppliers)

• 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA / 862.1095)

An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies.

• Alcohol Breath Trapping Device (FDA Code: DJZ / 862.3050)

A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

• Alcohol Dehydrogenase, Specific Reagent for Ethanol Enzyme Method (FDA Code: DIC / 862.3040)

An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

• 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.

• 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 Urinalysis System (FDA Code: KQO / 862.2900)

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

• 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.

• 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.

• Bilirubin and Conjugates Colorimetric Azo-Dyes Test (FDA Code: JJB / 862.1115)

A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.

• Blood Collection Lancet (FDA Code: FMK / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Campylobacter Pylori (FDA Code: LYR / 866.3110)

• 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.

• Clinical Refractometer (FDA Code: JRE / 862.2800)

A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.

• Cocaine and Cocaine Metabolites Enzyme Immunoassay Test (FDA Code: DIO / 862.3250)

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

• Continuous Electronic Thermometer (FDA Code: FLL / 880.2910)

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

• Follicle Stimulating Hormone Radioimmunoassay (FDA Code: CGJ / 862.1300)

A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

• 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.

• HCG Over The Counter Pregnancy Test Kit (FDA Code: LCX / 862.1155)

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.

• Human Chorionic Gonadotropin Radioimmunoassay (FDA Code: JHI / 862.1155)

• Infectious Mononucleosis Test System (FDA Code: KTN / 866.5640)

An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.

• Luteinizing Hormone Radioimmunoassay (FDA Code: CEP / 862.1485)

A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

• Methadone Enzyme Immunoassay Test (FDA Code: DJR / 862.3620)

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

• Methamphetamine Gas Chromatography Test (FDA Code: LAF / 862.3610)

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

• Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN / 870.1130)

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

• Non-Quantitative Urobilinogen Test (FDA Code: CDM / 862.1785)

A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.

• Occult Blood in Urine Test (FDA Code: JIO / 864.6550)

An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

• Opiates Enzyme Immunoassay Test (FDA Code: DJG / 862.3650)

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

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

• Phencyclidine Enzyme Immunoassay (FDA Code: LCM)

• Propoxyphene Enzyme Immunoassay (FDA Code: JXN / 862.3700)

A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.

• Streptococcus Spp Antigen (FDA Code: GTY / 866.3740)

• Tricyclic Antidepressant Drugs Radioimmunoassay Test (FDA Code: LFG / 862.3910)

A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.

• Urinary Enzymatic Method (FDA Code: JIL / 862.1340)

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

• Urinary Ketones, Nitroprusside Test (FDA Code: JIN / 862.1435)

A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.

• Urinary Nitrite Colorimetric Test (FDA Code: JMT / 862.1510)

A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.

• Urinary pH Dye Indicator (FDA Code: CEN / 862.1550)

A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

• Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR / 862.1645)

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

• Urine Leukocyte Test (FDA Code: LJX / 864.7675)

A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.