Health Chem Diagnostics LLC

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Web: http://www.healthchemdiagnostics.com
E-Mail: [EMail]info@healthchemdiagnostics.com
Address: 3341 S.W. 15th St., Pompano Beach, Florida 33069-4808, USA
Phone: +1-(954)-979-3845 | Fax: +1-(954)-979-7997 | Map/Directions >>
 
 

Profile: Health Chem Diagnostics LLC manufactures point-of-care medical diagnostic products for use at home, in physician office, and in other healthcare locations & markets. Our products are alcohol testing, family planning, cancer screening, cardiac markers, cholesterol testing, and saliva testing kits. Our TriMeter TM Glucose complete diabetes care system uses only 2-5 microliters of blood and gives results in 15 secs or less. Our Sani-Sal® saliva collection device is used for uniform collection of saliva as an analytical medium. It provides a saliva sample which contains low molecular weight compounds, hormones, enzymes and proteins in levels that are representative of that in serum or plasma. The foam composition of the device does not absorb the analytes under consideration for analysis such as drugs of abuse, hormones, therapeutic drugs, vitamins or proteins. Our foot health diabetic neuropathy tester is made of medical grade adhesive foam. The device forms a pocket which traps humidity allowing the chemistry to detect normal skin permeation. It has three circular indicators that will change color based on different humidity conditions indicating moisture transmission as normal or impaired.

FDA Registration Number: 1048532

1 to 50 of 74 Products/Services (Click for related suppliers)  Page: [1] 2 >> Next 50 Results
• Abnormal Plasma Control (FDA Code: GGC / 864.5425)
A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
• Activated Partial Thromboplastin (FDA Code: GFO / 864.7925)
A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
• Albumin Antigen Antiserum Control (FDA Code: DCF / 866.5040)
An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
• 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.
• Alpha-Fetoprotein Rapid Test Strip
• Alpha-Ketobutyric Acid and NADH (FDA Code: JMK / 862.1380)
A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.
• 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.
• 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.
• Blood Cell Diluent (FDA Code: GIF / 864.8200)
A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
• BreathScanr Alcohol Detector
• 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.
• Cardiac Markers
• Cholesterol Colorimetric Test (FDA Code: CGO / 862.1175)
A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
• Cholesterol Testing and Cholesterol Monitoring Kits
• Coagulation Factor Deficient Plasma (FDA Code: GJT / 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).
• 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.
• Colorimetric SGPT Test (FDA Code: CKD / 862.1030)
An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
• Control Thromboplastin Reagent (FDA Code: GGO / 864.7925)
• Desoxycorticosterone Radioimmunoassay Test (FDA Code: JLE / 862.1250)
A desoxycorticosterone test system is a device intended to measure desoxycorticosterone (DOC) in plasma and urine. DOC measurements are used in the diagnosis and treatment of patients with hypermineralocorticoidism (excess retention of sodium and loss of potassium) and other disorders of the adrenal gland.
• Drug Mixture Control Materials (FDA Code: DIF / 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.
• Electrolyte Control (FDA Code: JJR / 862.1660)
• Enzymatic Esterase-Oxidase, Cholesterol (FDA Code: CHH / 862.1175)
• Enzyme Controls (FDA Code: JJT / 862.1660)
• Fecal Occult Blood Test Strip
• Fertility Monitors, Pregnancy Test Kits
• 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.
• Globulin Tryptophan Measurement (Colorimetric) (FDA Code: JGC / 862.1330)
A globulin test system is a device intended to measure globulins (proteins) in plasma and serum. Measurements of globulin are used in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.
• 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)
• Human/Horse/Rabbit Coagulase Plasma (FDA Code: JTL / 866.2160)
Coagulase plasma is a device that consists of freeze-dried animal or human plasma that is intended for medical purposes to perform coagulase tests primarily on staphylococcal bacteria. When reconstituted, the fluid plasma is clotted by the action of the enzyme coagulase which is produced by pathogenic staphylococci. Test results are used primarily as an aid in the diagnosis of disease caused by pathogenic bacteria belonging to the genusStaphylococcus and provide epidemiological information on disease caused by these microorganisms.
• IGA Control (FDA Code: CZP / 866.5510)
An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
• IgE Control (FDA Code: DGC / 866.5510)
• Immunoglobulin M (IgM) (FDA Code: DFT / 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.
• Immunoreactive Insulin Radioimmunoassay Test (FDA Code: CFP / 862.1405)
An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.
• Infectious Disease Test Kits
• Lactate Dehydrogenase NAD Reduction/NADH Oxidation (FDA Code: CFJ / 862.1440)
A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.
• 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.
• Microorganism Differentiation Strip and Reagent Disc (FDA Code: JTO / 866.2660)
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
• 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.)
• Nadh Oxidation/Nad Reduction (FDA Code: CKA / 862.1030)
• Normal And Abnormal Hemoglobin Standards And Controls (FDA Code: GFS / 864.8625)
A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
• Normal Control Plasma (FDA Code: GIZ / 864.5425)
• 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)
• Phospholipids Chromatographic (FDA Code: JNT / 862.1575)
A phospholipid test system is a device intended to measure phospholipids in serum and plasma. Measurements of phospholipids are used in the diagnosis and treatment of disorders involving lipid (fat) metabolism.
• Plasma Coagulation Control (FDA Code: GGN / 864.5425)

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