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31 matching records for DETECT®.
FDA Labels#
GMDN Terms#
Single-hole nuclear medicine system collimator, straight-bore
An individual hollow-bore cylinder made of a dense material, e.g., lead (Pb), tungsten (W) or titanium (Ti), used to ensure that only gamma ray activity directly in front of the collimator channel reaches the scintillation crystal of the imaging or detector...
Flat panel x-ray detector integration unit
A portable, electrically-powered device intended to enable a direct flat panel detector (not included) to be integrated as part of an analogue x-ray [i.e., screen-film, computerized radiography (plate)] system to convert the analogue x-ray system into a dig...
Nucleic acid hybridization detection IVD, probe
A defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to ident...
Cerebral oximeter
A mains electricity (AC-powered) photoelectric device that noninvasively measures the brain tissue blood oxygen saturation and venous oxygen saturation in the brain. It is typically used as an adjunct monitor for the regional haemoglobin oxygen saturation o...
Intravenous injection automated detection/documentation system processor/transmitter
A noninvasive electronic component of an intravenous (IV) injection automated detection/documentation system, intended to electronically interface with a system sensor to: 1) provide power to, and extract IV bolus injection volume data from, the sensor; and...
Thyroid-uptake nuclear medicine system
An assembly of diagnostic devices that comprise a non-imaging nuclear medicine system designed primarily for radioactive iodine related thyroid uptake measurement and analysis applications. It can typically be upgraded with the addition of software and hard...
Flat panel x-ray detector/film cassette weight-bearing protector
A device intended to cover a flat panel x-ray detector or film cassette (neither included) on which a patient stands, to protect the cassette/detector from the patient’s body weight during a computed or digital radiography procedure of the feet. It is made ...
Intravenous injection automated detection/documentation system computer
An electronic component of an intravenous (IV) injection automated detection/documentation system, intended to electronically receive IV bolus injection data (time, drug, dosage) from the system processor/transmitter and document the data [e.g., within the ...
Single-hole nuclear medicine system collimator, pinhole
A conical shaped housing of lead or equivalent material with a single small opening of a fixed diameter at the tapered end of the cone. It projects an inverted image of photon distribution onto the system's crystal detector ensuring that only gamma ray acti...
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.
Nucleic acid hybridization detection IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clin...
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and...
Bed/chair occupant movement sensor
An electrically-powered electronic sensing pad (pressure- or mechanical vibration-sensing) designed to be placed under a bed and/or chair occupant to detect and/or measure occupant movement related to activities such as sleep, wakefulness, and/or bed/chair ...
Immunohistochemistry antibody detection IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an immunohistochemistry assay that is used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers...
Bed/chair occupant movement pressure/vibration sensor
An electrically-powered electronic sensing pad (pressure- or mechanical vibration-sensing) designed to be placed under a bed and/or chair occupant to detect and/or measure occupant movement related to activities such as sleep, wakefulness, and/or bed/chair ...
Cardiopulmonary bypass system air bubble/fluid level detector
A mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the ve...
Diagnostic x-ray digital imaging conversion system
An assembly of medical devices designed to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. As a system it consists of both: 1) a ...
Electronystagmograph
A graphic recorder used for detecting the electrical potential caused by eye movements. This recorder includes an electrode for each eye and one on the forehead (multichannel recording) for measuring the potential from both eyes simultaneously, or repositio...
Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
One or multiple immunoglobulins sourced from an animal (e.g., goat, sheep, mouse, rabbit) intended to be used in combination with other IVDs for the qualitative and/or quantitative detection of antihuman immunoglobulin G (IgG) antibodies. The immunoglobulin...
Nucleic acid hybridization detection IVD, control
A material which is used to verify the performance of an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridizat...
Albumin IVD, kit, spectrophotometry
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using a spectrophotometry method. It is typically used for the detection of small amounts of alb...
Multiple solid tumour differentiation marker IVD, antibody
Multiple immunoglobulins (antibody cocktail) capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple proteins/markers associated with more than one specific tissue or solid ...
Haemoglobin detection IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of haemoglobin in a clinical specimen.
Arrythmia-detection blood pressure ambulatory recorder
An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for the 24-hour recording of blood pressure and detection of cardiac arrythmias [e.g., atrial fibrillation (AF)]; it may in addition measure the heart rate ...
Bone absorptiometric ultrasound system
An assembly of devices used to produce bone density measurements and other calculations based on data obtained from transmitted and reflected ultrasound (US) waves. Also called a bone densitometer, it has an integrated ultrasound transducer to deliver an ul...
Multiple solid tumour differentiation marker IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple proteins/markers associated with more than one specific tissue or solid tumour (e.g., lung, breast, ovarian, kidney, ga...
Haemoglobin detection IVD, antibody
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of haemoglobin in a clinical specimen.
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, agglutination, rapid
A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit...
Epstein-Barr virus (EBV) heterophile antibody IVD, kit, immunochromatographic test (ICT), rapid
A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of heterophile antibodies produced in response to Epstein-Barr virus (EBV) in a clinical specimen within a short period, relat...
Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-H...