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Automated Radioimmunoassay Systems,Automated Urinalysis Chemistry Analyzer Suppliers & Manufacturers

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Automated Radioimmunoassay Systems (FDA Code: LCI / 862.205)

Identification. 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.

Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 862.9. The device is also 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, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Stryker, DRG International, Inc., DiaSorin S.p.A., more...

Automated Urinalysis Chemistry Analyzer
Iris Diagnostics, Siemens Healthcare Diagnostics

Automated Urinalysis System (FDA Code: KQO / 862.29)
Automated Urinalysis System offers increased accuracy, sensitivity and objective quantifiable determinations of urinary constituents for better diagnostic interpretation of the test results of urine. The automated urinalysis system enables a technician to take a sample of urine and place it on an auto analyzer that contains the system reagent materials for the referenced tests, start the self-operating analyzer and walk away to other duties until the results are reported by the analyzer.

Identification. 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.

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.

Teco Diagnostics, Iris Diagnostics, Jant Pharmacal Corp., more...

Bacterial Sialidase Vaginal Test (FDA Code: MXB / 866.266)

Identification. 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.

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 866.9.

Gryphus Diagnostics, L.L.C.

Bacteriological Safety Enclosure
The Baker Company, Nuaire, Inc., Labconco, more...

Balance for General Use
Precisa Balances USA Inc., Mettler Toledo International Inc., Panos Th. Skoutas S.A., more...

Benzodiazepines Test Strip
Biomerica, ACON Laboratories, Inc., Inova Diagnostics, Inc., more...

Bichromatic Photometric Chemistry Analyzer
Abaxis, Inc

Bile Acids Cholyglycine Radioimmunoassay (FDA Code: KWW / 862.1177)

Identification. A cholylglycine test system is a device intended to measure the bile acid cholylglycine in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.

Classification. Class II.

Teco Diagnostics, Diazyme Laboratories, Rapid Diagnostics, more...

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

Identification. 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.

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.

Teco Diagnostics, Diagnostic Automation, Inc., Iris Diagnostics, more...

Bilirubin Diazo Colorimetry Test (FDA Code: CIG / 862.111)

Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Classification. Class II.

Teco Diagnostics, Diazyme Laboratories, Abaxis, Inc, more...

Bilirubin Enzymatic Method Test (FDA Code: JFM / 862.111)

Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Classification. Class II.

Diazyme Laboratories, Siemens Healthcare Diagnostics, Hemagen Diagnostics, Inc., more...

Bilirubinometer
Advanced Instruments, Inc., Wako Diagnostics, International Light Technologies, Inc., more...

Biological Laboratory Freezer
Helmer Scientific, Thermo Fisher Scientific Inc, New Brunswick Scientific Co., Inc., more...

Biotinidase Test System (FDA Code: NAK / 862.1118)

Identification. The biotinidase test system is an in vitro diagnostic device intended to measure the activity of the enzyme biotinidase in blood. Measurements of biotinidase are used in the treatment and diagnosis of biotinidase deficiency, an inborn error of metabolism in infants, characterized by the inability to utilize dietary protein bound vitamin or to recycle endogenous biotin. The deficiency may result in irreversible neurological impairment.

Classification. Class II (special controls). The special control is sale, distribution, and use in accordance with the prescription device requirements in 801.109 of this chapter.

PerkinElmer, Inc.(LAS), Astoria-Pacific, Inc.

Black Stopper Blood Collection Tube
Exel International Medical Products, Siemens Healthcare Diagnostics, Covidien, more...

Blender/Mixer (FDA Code: JRO / 862.205)

Identification. 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.

Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 862.9. The device is also 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, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

Sysmex America, Inc., Solutek Corporation, Vulcon Technologies, more...

Blood Alcohol Kit (Excludes Hiv Testing) (FDA Code: OIC / 862.304)

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.

Kidder Industrial Limited, Path-Tec, LLC, Sirchie Finger Print Laboratories, more...

Blood And Urine Collection Kit (Excludes Hiv Testing) (FDA Code: OIB / 864.325)

Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Classification. Class II.

Endochoice, Inc., Fitzco, Inc., Brook-Yates Center Diversified Opportunities, more...

Blood Collection Systems (FDA Code: JKA / 862.1675)

Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Classification. Class II.

Teco Diagnostics, Hycor Biomedical Inc., Bio-Rad Laboratories, Inc., more...

Blood Collection Tube
Exel International Medical Products, Siemens Healthcare Diagnostics, Fisher Scientific International, Inc., more...

Blood Collection Tube Holder
Exel International Medical Products, Siemens Healthcare Diagnostics, Fisher Scientific International, Inc., more...

Blood Gas and Ph Electrode Measurement (FDA Code: CHL / 862.112)

Identification. A blood gases (PCO2, PO2) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Classification. Class II.

Osmetech, Inc., Siemens Healthcare Diagnostics, Instrumentation Laboratory (IL), more...

Blood Gas Controls (FDA Code: JJS / 862.166)

Identification. 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.

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

Bio-Rad Laboratories, Inc., Siemens Healthcare Diagnostics, Diamond Diagnostics, Inc, more...

Blood Leak Test Strips
Inova Diagnostics, Inc., ACON Laboratories, Inc., Schueler & Company Inc, more...

Blood Microcollection Tube
Siemens Healthcare Diagnostics, RAM Scientific, Inc., Omega Medical Electronics Ltd., more...

Blood pH Meter
Fisher Scientific International, Inc., Radiometer America Inc., Radiometer Ltd., more...

Blood Urea Nitrogen (BUN) Reagent
Hemagen Diagnostics, Inc., Stanbio Laboratory, Beckman Coulter, Inc., more...

Blue Stopper Blood Collection Tube
Exel International Medical Products, Siemens Healthcare Diagnostics, Covidien, more...

Breath Measurement System (FDA Code: NRH / 862.182)

Identification. A xylose test system is a device intended to measure xylose (a sugar) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (a group of disorders in which there is subnormal absorption of dietary constituents and thus excessive loss from the body of the nonabsorbed substances).

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.

Vyaire Medical, Inc., Medical Diagnostics And Supplies Incorporated

Breath Nitric Oxide Test System (FDA Code: MXA / 862.308)

Identification. A breath nitric oxide test system is a device intended to measure fractional nitric oxide in human breath. Measurement of changes in fractional nitric oxide concentration in expired breath aids in evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to established clinical and laboratory assessments of asthma. A breath nitric oxide test system combines chemiluminescence detection of nitric oxide with a pneumotachograph, display, and dedicated software.

Classification. Class II (special controls). The special control is FDA's guidance entitled "Class II Special Controls Guidance Document: Breath Nitric Oxide Test System." See 862.1(d) for the availability of this guidance document.

Sanmina-SCI USA, Inc., Apieron, Aerocrine Ab

Bromcresol Green Dye-Binding, Albumin (FDA Code: CIX / 862.1035)

Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Classification. Class II.

Teco Diagnostics, International Bio-Analytical Industries, Inc., Abbott Diagnostics, more...

Brown Stopper Blood Collection Tube
Exel International Medical Products, Siemens Healthcare Diagnostics, Covidien, more...

BUN (Blood Urea Nitrogen) Analyzer
Siemens Healthcare Diagnostics, Beckman Coulter, Inc., Wiener Laboratorios SAIC

Burner
Fisher Scientific International, Inc., Bellco Glass, Inc., Wall Lenk Corporation, more...

C Peptides of Proinsulin Radioimmunoassay Test (FDA Code: JKD / 862.1135)

Identification. 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.

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.

Calbiotech, Inc., Siemens Healthcare Diagnostics, PerkinElmer, Inc.(LAS), more...

Calcitonin Radioimmunoassay Test (FDA Code: JKR / 862.114)

Identification. 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).

Classification. Class II.

Biomerica, Nichols Institute Diagnostics, Scantibodies Laboratory, Inc., more...

Calcium Atomic Absorption Test (FDA Code: JFN / 862.1145)

Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Classification. Class II.

Abaxis, Inc, Beckman Coulter, Inc., Synermed Intl., Inc.

Calcium Azo-Dye (FDA Code: CJY / 862.1145)

Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Classification. Class II.

Abaxis, Inc, Abbott Diagnostics, Siemens Healthcare Diagnostics, more...

Calcium Cresolphthalein Complexone Test (FDA Code: CIC / 862.1145)

Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Classification. Class II.

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

Calcium Ion Specific Electrode (FDA Code: JFP / 862.1145)

Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Classification. Class II.

Teco Diagnostics, Osmetech, Inc., Siemens Healthcare Diagnostics, more...

Calcium Titrator
Fisher Scientific International, Inc.

Calorimeter
Perkinelmer, Inc., Utech Products, Inc., Scientech, Inc., more...

Capillary Tube Accessories
World Precision Instruments, Inc., Siemens Healthcare Diagnostics, Spectra Medical Devices, Inc., more...

Capillary Tube Sealers
World Precision Instruments, Inc., Siemens Healthcare Diagnostics, Spectra Medical Devices, Inc., more...

Carbohydrate Deficient Transferrin Test (FDA Code: NAO / 862.136)

Identification. A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

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.

Siemens Healthcare Diagnostics, Sebia Electrophoresis, Axis-Shield Asa, more...

Carbohydrate Standard
Siemens Healthcare Diagnostics, Accurate Chemical & Scientific Corp.

Carbon Analyzer
Siemens Healthcare Diagnostics, Perkinelmer, Inc., UIC, Inc.

Carbon Hydrogen Analyzer
Perkinelmer, Inc.

Carbon Hydrogen Nitrogen Analyzer
Perkinelmer, Inc., Applitek N.V.

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