Lin-Zhi International, Inc.

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Web: http://lin-zhi.com
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Address: 687 North Pastoria Ave., Sunnyvale, California 94085-2917, USA
Phone: +1-(408)-732-3856 | Fax: +1-(408)-732-3849 | Map/Directions >>

Profile: Lin-Zhi International, Inc. is a provider of products for clinical diagnostics. Our product line includes drugs, medicines and clinical reagents, antibodies, laboratory supplies, clinical reagents, drug testing equipment, enzymes, laboratory reagents, enzyme immunoassay equipment, medical device research and technology development, monoclonal antibodies & laboratory enzyme analyzers. We also offer homogeneous EIA reagents for simultaneous detection of multiple analytes in urine.

The company was founded in 2001, has revenues of USD 1-5 Million, has ~10 employees.

FDA Registration Number: 3003610499

19 Products/Services (Click for related suppliers)

• Alcohol Control Materials (FDA Code: DKC / 862.3280)

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

• 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.

• 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.

• 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.

• Diagnostic Reagents

• Drug Mixture Calibrator (FDA Code: DKB / 862.3200)

A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also 862.2 in this part.)

• Drug Mixture Control Materials (FDA Code: DIF / 862.3280)

• Drug Specific Calibrator (FDA Code: DLJ / 862.3200)

• Drug Specific Control Test (FDA Code: LAS / 862.3280)

• Enzyme Immunoassay

• Ethyl Alcohol Calibrator Test (FDA Code: DNN / 862.3200)

• Glc Liquid Coating (FDA Code: DLG / 862.2250)

A gas liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid coating.

• Homogeneous Enzyme Immunoassays

• Metamphetamine Thin Layer Chromatography Test (FDA Code: DJC / 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.

• 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.

• 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.

• 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.