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MEDICAL products beginning with : A
151 to 200 of 2962 results  Page: << Previous 50 Results 1 2 3 [4] 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 >> Next 50 Results
 PRODUCT NAMEFDA Code/Regulation 
Alpha-1-Acid-Glycoprotein Antigen (18 suppliers)

Identification. Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

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.

LKL / 866.5420
Alpha-1-Antichymotrypsin (2 suppliers)

Identification. Analpha -1-antichymotrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha -1-antichymotrypsin (a protein) in serum, other body fluids, and tissues.Alpha -1-antichymotrypsin helps protect tissues against proteolytic (protein-splitting) enzymes released during infection.

Classification. Class II (performance standards).

DFF / 866.5080
Alpha-1-Antitrypsin (17 suppliers)

Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.

Classification. Class II (performance standards).

DEM / 866.5130
Alpha-1-B-Glycoprotein Antiserum Antigen Control (2 suppliers)

Identification. Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

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.

DEX / 866.5420
Alpha-1-Lipoprotein (8 suppliers)

Identification. Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement ofalpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).

Classification. Class II (performance standards).

DER / 866.5580
Alpha-1-T-Glycoprotein (1 supplier)

Identification. Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

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.

DEN / 866.5420
Alpha-2-AP-Glycoprotein (1 supplier)

Identification. Analpha -2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-glycoproteins (a group of plasma proteins found in thealpha- 2 group when subjected to electrophoresis) in serum and other body fluids. Measurement ofalpha -2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.

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.

DAW / 866.5425
Alpha-2-Glycoproteins (2 suppliers)

Identification. Analpha -2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-glycoproteins (a group of plasma proteins found in thealpha- 2 group when subjected to electrophoresis) in serum and other body fluids. Measurement ofalpha -2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.

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.

DEJ / 866.5425
Alpha-2-HS-Glycoprotein (5 suppliers)

Identification. Analpha -2-glycoproteins immunolgical test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-glycoproteins (a group of plasma proteins found in thealpha- 2 group when subjected to electrophoresis) in serum and other body fluids. Measurement ofalpha -2-glycoproteins aids in the diagnosis of some cancers and genetically inherited deficiencies of these plasma proteins.

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.

DEF / 866.5425
Alpha-2-Macroglobulin (5 suppliers)

Identification. Analpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-macroglobulin (a serum protein) in plasma. Measurement ofalpha -2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

Classification. Class II (performance standards).

DEB / 866.5620
Alpha-Fetoprotein for Testicular Cancer Test Kit (13 suppliers)

Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled "Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA," and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

LOJ / 866.6010
Alpha-Fetoprotein RIA Test System (2 suppliers)KTJ
Alpha-Fetoprotein Test for Neural Tube Defect Test (5 suppliers)LOK
Alpha-Globulin Antiserum Antigen Control (3 suppliers)

Identification. Analpha- globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- globulin (a serum protein) in serum and other body fluids. Measurement ofalpha- globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.

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.

DCO / 866.5400
Alpha-Ketobutyric Acid and NADH (12 suppliers)

Identification. 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.

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 the limitations in 862.9.

JMK / 862.1380
Alt/Sgpt Diazo (2 suppliers)

Identification. 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.

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.

CJJ / 862.1030
ALT/SGPT Vanillin Pyruvate Test (2 suppliers)

Identification. 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.

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.

CKC / 862.1030
Alterable Preformed Skull Bone Plate (4 suppliers)

Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

Classification. Class II (performance standards).

GWO / 882.5320
Alternating Pressure Air Flotation Mattress (96 suppliers)

Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).

Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 880.9.

FNM / 880.5550
Ambulatory Electrocardiograph (24 suppliers)

Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Classification. Class II (performance standards).

MWJ / 870.2800
Ambulatory Electrocardiograph (ECG) Analysis Systems (22 suppliers)

Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Classification. Class II (performance standards).

MLO / 870.2800
Amibacin Fluorescence Polarization Immunoassay (1 supplier)

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.

LGJ / 862.3035
Amikacin Radioimmunoassay Test (4 suppliers)

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.

KLQ / 862.3035
Amikacin Serum Assay Test (4 suppliers)

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.

KLP / 862.3035
Amino Acid Assay Culture Media (5 suppliers)

Identification. A microbiological assay culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate selected test microorganisms in order to measure by microbiological procedures the concentration in a patient's serum of certain substances, such as amino acids, antimicrobial agents, and vitamins. The concentration of these substances is measured by their ability to promote or inhibit the growth of the test organism in the innoculated medium. Test results aid in the diagnosis of disease resulting from either deficient or excessive amounts of these substances in a patient's serum. Tests results may also be used to monitor the effects of the administration of certain antimicrobial drugs.

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 the limitations in 866.9.

JRZ / 866.2350
Amino-Nitrogen (1 supplier)

Identification. A nitrogen (amino-nitrogen) test system is a device intended to measure amino acid nitrogen levels in serum, plasma, and urine. Nitrogen (amino-nitrogen) measurements are used in the diagnosis and treatment of certain forms of severe liver disease and renal disorders.

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 the limitations in 862.9.

JMX / 862.1515
Ammonia Enzymatic Method Test (12 suppliers)

Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Classification. Class I.

JIF / 862.1065
Ammonia Photometric Method (1 supplier)

Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Classification. Class I.

JID / 862.1065
Ammoniacal Silver Hydroxide Silver Nitrate Stain (6 suppliers)

Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are 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.

ICZ / 864.1850
Amniotic Fluid Sampler (21 suppliers)

Identification. The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity.

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 the limitations in 884.9.

HIO / 884.1550
Amniotome (28 suppliers)

Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

Classification. (1) Class II (performance standards).

HGE / 884.4530
Amphetamine Enzyme Immunoassay Test (65 suppliers)

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.

DKZ / 862.3100
Amphetamine Gas Chromatography Test (5 suppliers)

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.

DOD / 862.3100
Amphetamine Liquid Chromatography Test (2 suppliers)

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.

DNI / 862.3100
Amphetamine Radioimmunoassay Test (2 suppliers)

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.

DJP / 862.3100
Amphetamine Thin Layer Chromatography (3 suppliers)

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.

DIT / 862.3100
Amplifier & Transducer Pressure External Recorder (2 suppliers)

Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.

Classification. Class II (performance standards).

FES / 876.1725
Amplitude-Integrated Electroencephalograph (2 suppliers)

Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Classification. Class II (performance standards).

OMA / 882.1400
Amputation Knife (56 suppliers)

Identification. 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.

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 the limitations in 878.9.

GDN / 878.4800
Amsler Grid (6 suppliers)

Identification. An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.

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 the limitations in 886.9. 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.

HOQ / 886.1330
Amylase Catalytic Method Test (31 suppliers)

Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Classification. Class II.

JFJ / 862.1070
Amylase Nephelometric (5 suppliers)

Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Classification. Class II.

KHM / 862.1070
Amylase Nitrosalicylate Reduction Test (1 supplier)

Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Classification. Class II.

CJD / 862.1070
Amylase Saccharogenic Test (10 suppliers)

Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Classification. Class II.

CIJ / 862.1070
Amylase Starch-Dye Bound Polymer Test (8 suppliers)

Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Classification. Class II.

CIW / 862.1070
Amyloclastic, Amylase (9 suppliers)

Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Classification. Class II.

CJA / 862.1070
Anaerobic Glove Box (31 suppliers)

Identification. An anaerobic chamber is a device intended for medical purposes to maintain an anaerobic (oxygen free) environment. It is used to isolate and cultivate anaerobic microorganisms.

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 the limitations in 866.9. The device is also exempt from the 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.

JTM / 866.2120
Anaerobic Identification Kit Test (10 suppliers)

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.

JSP / 866.2660
Anaerobic Transport Culture Media (7 suppliers)

Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

Classification. Class I (general controls).

JSL / 866.2390
Anaerobic Transport System (6 suppliers)

Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Classification. Class I (general controls).

JTX / 866.2900
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