2nd Antibody Sep. Goat Antibody Digoxin (125-I) Radioimmunoassay,2nd Antibody Sep. Goat Antibody Digoxin (3-H) Radioimmunoassay Suppliers & Manufacturers

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2nd Antibody Sep. Goat Antibody Digoxin (125-I) Radioimmunoassay (FDA Code: DNJ / 862.3320)

Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Classification. Class II.

Mallinckrodt

2nd Antibody Sep. Goat Antibody Digoxin (3-H) Radioimmunoassay (FDA Code: DOY / 862.3320)

Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Classification. Class II.

Arrow Internacional De Mexico, S.A. De C.V.

Acetaminophen Colorimetry Test (FDA Code: LDP / 862.3030)

Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

Classification. Class II.

Biosite Incorporated, International Bio-Analytical Industries, Inc., Siemens Healthcare Diagnostics, more...

Acetylcholine Chloride Reagent (FDA Code: DLI / 862.3240)

Identification. 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).

Classification. Class I.

Siemens Healthcare Diagnostics, Hemagen Diagnostics, Inc., Roche Diagnostics, more...

Adsorbent Liquid Chromatography (FDA Code: DMZ / 862.2260)

Identification. A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Alltech Associates, Inc.

Alcohol Analyzer
Alcohol-Analyzer.com, Akers Biosciences, Inc., Analox Instruments Ltd., more...

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

Identification. 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.

Classification. Class I.

ACON Laboratories, Inc., Inverness Medical Innovations, Inc., Akers Biosciences, Inc., more...

Alcohol Control Materials (FDA Code: DKC / 862.3280)

Identification. 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.

Classification. Class I (general controls). Except when used in donor screening, unassayed material is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Remel, Aalto Scientific Ltd, Clinical Controls International, more...

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

Identification. 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.

Classification. Class II.

ACON Laboratories, Inc., Siemens Healthcare Diagnostics, Genzyme Biosurgery, more...

Alcohol Potassium Dichromate Test (FDA Code: DOJ / 862.3040)

Identification. 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.

Classification. Class II.

Varian Medical Systems, Inc.

Amibacin Fluorescence Polarization Immunoassay (FDA Code: LGJ / 862.3035)

Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.

Classification. Class II.

Roche Diagnostics Gmbh

Amikacin Radioimmunoassay Test (FDA Code: KLQ / 862.3035)

Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.

Classification. Class II.

Siemens Healthcare Diagnostics, Remel, Abbott Hematology, more...

Amikacin Serum Assay Test (FDA Code: KLP / 862.3035)

Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.

Classification. Class II.

Roche Diagnostics, Randox Laboratories Ltd., Roche Diagnostics Gmbh, more...

Amphetamine Enzyme Immunoassay Test (FDA Code: DKZ / 862.3100)

Identification. 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.

Classification. Class II.

Teco Diagnostics, Diagnostic Automation, Inc., Jant Pharmacal Corp., more...

Amphetamine Gas Chromatography Test (FDA Code: DOD / 862.3100)

Identification. 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.

Classification. Class II.

Varian, Inc., Olympus America, Inc., Ameritek U.S.A., more...

Amphetamine Liquid Chromatography Test (FDA Code: DNI / 862.3100)

Identification. 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.

Classification. Class II.

Bio-Rad Laboratories, Inc., Princeton BioMeditech Corp.

Amphetamine Radioimmunoassay Test (FDA Code: DJP / 862.3100)

Identification. 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.

Classification. Class II.

Siemens Healthcare Diagnostics, Rocky Mountain Diagnostics, Inc.

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

Identification. 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.

Classification. Class II.

Phamatech, Inc., DRG International, Inc., Lumiquick Diagnostics, Inc.

Anti-Seizure Drug Immunoassay (FDA Code: NWM / 862.3350)

Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

Classification. Class II.

Siemens Healthcare Diagnostics, Remel, Ark Diagnostics Inc

Bacillus Subtlis Microbiology Assay, Tobramycin (FDA Code: DID / 862.3900)

Identification. A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

Classification. Class II.

Beckman Coulter, Inc.

Barbiturate Enzyme Immunoassay Test (FDA Code: DIS / 862.3150)

Identification. 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.

Classification. Class II.

Teco Diagnostics, Diagnostic Automation, Inc., Jant Pharmacal Corp., more...

Barbiturate Gas Liquid Chromatography Test (FDA Code: DMF / 862.3150)

Identification. 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.

Classification. Class II.

Varian, Inc.

Barbiturate High Pressure Liquid Chromatography Test (FDA Code: KZY / 862.3150)

Identification. 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.

Classification. Class II.

Varian, Inc., Beckman Coulter, Inc.

Barbiturate Radioimmunoassay Test (FDA Code: DKN / 862.3150)

Identification. 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.

Classification. Class II.

Siemens Healthcare Diagnostics, Princeton BioMeditech Corp., Diagnostic Test Group, Llc

Benzodiazepine Enzyme Immunoassay Test (FDA Code: JXM / 862.3170)

Identification. 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.

Classification. Class II.

Teco Diagnostics, Diagnostic Automation, Inc., Jant Pharmacal Corp., more...

Benzodiazepine Gas Chromatography Test (FDA Code: KZZ / 862.3170)

Identification. 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.

Classification. Class II.

Varian, Inc.

Benzodiazepine High Pressure Liquid Chromatography Test (FDA Code: LAA / 862.3170)

Identification. 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.

Classification. Class II.

Bio-Rad Laboratories, Inc., Varian, Inc., Beckman Coulter, Inc.

Benzodiazipine Thin Layer Chromatography (FDA Code: LAB / 862.3170)

Identification. 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.

Classification. Class II.

Lumiquick Diagnostics, Inc.

Benzoylecgnonine Thin Layer Chromatography Test (FDA Code: DOM / 862.3250)

Identification. 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.

Classification. Class II.

Jant Pharmacal Corp.

Blood Phase Oxyhemoglobin Concentration Analyzer (Non-Indwelling, Oxygen)
Instrumentation Laboratory (IL), Radiometer America Inc., AVL Medical Instruments (Japan)

Cannabinoid (S) Radioimmunoassay Test (FDA Code: LAT / 862.3870)

Identification. 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.

Classification. Class II.

Siemens Healthcare Diagnostics, Immunalysis Corporation, Psychemedics Corporation

Cannabinoids Enzyme Immunoassay Test (FDA Code: LDJ / 862.3870)

Identification. 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.

Classification. Class II.

Teco Diagnostics, Diagnostic Automation, Inc., Jant Pharmacal Corp., more...

Carbamazepine Enzyme Immunoassay Test (FDA Code: KLT / 862.3645)

Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

Classification. Class II.

Microgenics Corporation, Abbott Diagnostics, Siemens Healthcare Diagnostics, more...

Carbamazepine Fluorescence Polarization Immunoassay Test (FDA Code: LGI / 862.3645)

Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

Classification. Class II.

Oxis International, Inc., Abbott Hematology, Roche Diagnostics Gmbh, more...

Carbon Monoxide Test Reagent
Vitalograph, Inc.

Carbon-Monoxide Gas Chromatograph (FDA Code: JKT / 862.3220)

Identification. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.

Classification. Class I.

Chromato-Sud

Carbon-Monoxide Oxyhemoglobin/Carboxyhemoglobin Curve Test (FDA Code: JKS / 862.3220)

Identification. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.

Classification. Class I.

Masimo Corporation, Instrumentation Laboratory (IL), Nova Biomedical, more...

Cholinesterase Colorimetry Test (FDA Code: DIH / 862.3240)

Identification. 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).

Classification. Class I.

Teco Diagnostics, Siemens Healthcare Diagnostics, Remel, more...

Cholinesterase Test Paper (FDA Code: DIG / 862.3240)

Identification. 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).

Classification. Class I.

American Bio Medica Corp.

Chromatographic Barbiturate Identification Test (FDA Code: DKX / 862.3150)

Identification. 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.

Classification. Class II.

Diagnostic Automation, Inc., DRG International, Inc., Lumiquick Diagnostics, Inc., more...

Clinical Use Chromatography (Thin Layer) (FDA Code: KZS / 862.2270)

Identification. A thin-layer chromatography (TLC) system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. The mixture of compounds is absorbed onto a stationary phase or thin layer of inert material (e.g., cellulose, alumina, etc.) and eluted off by a moving solvent (moving phase) until equilibrium occurs between the two phases.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9. Particular components of TLC systems, i.e., the thin-layer chromatography apparatus, TLC atomizer, TLC developing tanks, and TLC ultraviolet light, are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.

Biodex Medical Systems, Inc.

Clinical Use Gas Chromatography (FDA Code: KZQ / 862.2250)

Identification. 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.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

CDS Analytical, Inc., QuinTron Instrument Company, Dani Germany, more...

Clinical Use Gel Liquid Chromatography (FDA Code: KZR / 862.2260)

Identification. A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Chromsystems Instruments & Chemicals Gmbh

Clinical Use Mass Spectrometer (FDA Code: DOP / 862.2860)

Identification. A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 862.9.

Bioanalytical Systems, Inc., Dionex Corporation, Headwall Photonics., more...

Coated Tube Sep. Rabbit Antibody Digoxin (125-I) Radioimmunoassay (FDA Code: DPO / 862.3320)

Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Classification. Class II.

DRG International, Inc., Rapid Diagnostics

Cocaine & Metabolites High Pressure Liquid Chromatography Test (FDA Code: LAC / 862.3250)

Identification. 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.

Classification. Class II.

Varian, Inc., Beckman Coulter, Inc.

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

Identification. 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.

Classification. Class II.

Teco Diagnostics, Diagnostic Automation, Inc., Jant Pharmacal Corp., more...

Cocaine Enzyme Immunoassay Test (FDA Code: JXO / 862.3250)

Identification. 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.

Classification. Class II.

Teco Diagnostics, Biosite Incorporated, Inverness Medical Innovations, Inc., more...

Cocaine Gas Chromatography Test (FDA Code: DIN / 862.3250)

Identification. 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.

Classification. Class II.

Varian, Inc.

Cocaine Metabolite Radioimmunoassay Test (FDA Code: KLN / 862.3250)

Identification. 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.

Classification. Class II.

Siemens Healthcare Diagnostics, Immunalysis Corporation, Psychemedics Corporation

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