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MEDICAL products beginning with : Q
1 to 50 of 68 results  Page: [1] 2 >> Next 50 Results
 PRODUCT NAMEFDA Code/Regulation 
Q Fever CF Antigen Test (5 suppliers)

Identification. Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genusRickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).

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.

GPS / 866.3500
Q Fever CF Antiserum Test (3 suppliers)

Identification. Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genusRickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).

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.

GPR / 866.3500
Q Fever Fluorescent Antiserum (2 suppliers)

Identification. Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genusRickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).

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.

GPJ / 866.3500
Qualitative and Quantitative Factor Deficiency Test (32 suppliers)

Identification. 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).

Classification. Class II (performance standards).

GGP / 864.7290
Qualitative Phenotype Alpha-1-Antitrypsin Kit (1 supplier)

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).

OBZ / 866.5130
Qualitative Test for Detection Of Dengue Igm And Igg Antibodies (2 suppliers)NWY
Quality Control Kit for Blood Banking Reagents (12 suppliers)

Identification. A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.

Classification. Class II (performance standards).

KSF / 864.9650
Quality Control Kits (30 suppliers)

Identification. A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each impregnated with a specified, freeze-dried, viable microorganism, intended for medical purposes to determine if a given culture medium is able to support the growth of that microorganism. 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). 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.

JTR / 866.2480
Quality Control Slide (17 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.

LJG / 866.2660
Quantitative Glucose-6-Phosphate Dehydrogenase (Erythrocytic) (2 suppliers)

Identification. An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.

Classification. Class II (performance standards).

JBL / 864.7360
Quinidine Enzyme Immunoassay Test (8 suppliers)

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.

LBZ / 862.3320
Quinine High Pressure Liquid Chromatography Test (1 supplier)

Identification. A quinine test system is a device intended to measure quinine, a fever-reducing and pain-relieving drug intended in the treatment of malaria, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of quinine overdose and malaria.

Classification. Class I.

LAM / 862.3750
Quality Control Equipment/Service (29 suppliers)
Quality Control Reagent (4 suppliers)
Quarter Globe Ophthalmic Cap (1 supplier)
Quantitative Digital Radiography Densitometer (4 suppliers)
Quality Testing Equipment (9 suppliers)
Quality Testing Control Service (9 suppliers)
Quantum Dosimeter Badge (2 suppliers)
Quick Carer System (1 supplier)
Q Fever IFA IgG (1 supplier)
Q Fever IFA IgM (1 supplier)
Quantitative Analysis Software for Radiology (1 supplier)
QVA (Quantitative Vascular Analysis) Software (1 supplier)
QIVA (Quantitative IntraVascular ultrasound Analysis) Software (1 supplier)
Quality Management Services (6 suppliers)
Q-Curver Catheters (1 supplier)
Q Fever Test Kits (2 suppliers)
Q Fever Test Kits contains 8-well dual antigen substrate slides, class specific anti-human fluorescein conjugate and negative & positive titered controls. This kit includes a specially formulated sample pretreatment diluent.
QCA Software Analysis Systems (3 suppliers)
Quinton Catheters (2 suppliers)
Quinton catheter is a double lumen tube inserted into a large vein and used to place a patient on a hemodialysis machine for renal failure. These are used for short-term and long-term peritoneal dialysis or intra-peritoneal chemotherapy.
Quantitative Coronary Analysis Software (1 supplier)
QRS Spirometer (1 supplier)
Quadripolar Catheter (1 supplier)
Quentin Catheter (1 supplier)
Quigong Machine (1 supplier)
Quigong Machine increases the extendibility of collagen tissues, helps reduces lines, wrinkles & stretch marks, increases blood flow & circulation, decreases joint stiffness, relieves muscle spasms & pain and soothes low back pain.
Quantitative Kinetic Determination Of Amylase Kit (5 suppliers)
Quantum II ELISA Systems (1 supplier)
Quick Connect Adaptors (1 supplier)
Quick Connect Adapters (1 supplier)
Quantitative Vessel Analysis For CTA (1 supplier)
Quantitative Vessel Analysis For MRA (1 supplier)
Quick Coupling Handle (1 supplier)
Queen Square Pattern Hammer (2 suppliers)
Quilted Underpad (2 suppliers)
Quilted underpad consists of 3-layers that includes stay-dry top layer and antibacterial - antifungal finish. It is reusable, absorbs, and traps liquids. It is made up of 80% cotton, and 20% polyester.
Quilted Limb Holder (1 supplier)
Quantitative Sensory Testing Kit (1 supplier)
Quality Assessment Programs (14 suppliers)
Quality Assurance (13 suppliers)
Quad Canes (24 suppliers)
Quality Assurance & Control (22 suppliers)
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