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Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen, using an ion-selective electrode (ISE) method.
Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE)
A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen, using an ion-selective electrode (ISE) method.
Blood pressure cuff multichannel valve unit
A non-powered device intended to interface between a blood pressure cuff inflator and multiple blood pressure cuffs to allow manual channel selection (i.e., allow one or more selected cuffs to be inflated without disconnection of non-selected cuffs). It is ...
Mechanical pipette
A manually-operated device typically used in the laboratory to withdraw, transfer, and inject discrete volumes of fluid materials. The device is typically hand-held and operates through an internal mechanism powered by the fingers; it can have a single chan...
Reverse-osmosis water purification system
An assembly of devices designed to remove unwanted contaminants (bacteria, viruses, chemicals, dissolved substances) from water using osmotic pressure applied to one side of a selective membrane. The system removes ions, large molecules (e.g. proteins, gluc...
Intravascular occluding balloon catheter, image-guided
A flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and in...
Inflatable penile prosthesis
An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity ...
Dermatological frequency-doubled solid-state laser system
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended to cut, excise, ablate, and vaporize soft tissues in dermatological applicat...
Inflatable hot/cold therapy pack/electric pump
A non-sterile assembly of devices intended for localized thermal and compression therapy to facilitate the treatment of a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot a...
Dermatological frequency-doubled solid-state laser system
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended to cut, excise, ablate, and vaporize soft tissues in dermatological applicat...
Cryolipolysis body contouring system program card
A portable electronic device designed to connect to the data port of a cryolipolysis body contouring system to provide its control unit with a selected treatment profile. It contains data such as cooling intensity factor (CIF), cycle time and other relevant...
Ion selective electrode (ISE) reference solution IVD, reagent
A substance or reactant intended to be used together with a reference electrode to perform a specific function in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.
Active-implantable-device communicator
A non-sterile electronic device, typically hand-held, intended to be used to communicate (e.g., via radio-frequency) with an active implantable device (e.g., a pulse generator) to receive information on device and/or physiologic performance, and/or to selec...
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, using a n...
HLA class II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple HLA class II antigens in a clinical specimen, using a nucleic acid technique (NAT). It may be ...
Vitrectomy sutureless lens holding ring, reusable
A non-sterile device in the form of a small circular ring designed to contain a selected vitrectomy sutureless lens (VSL) within its confines to hold the lens in the correct position directly to the front surface of the eye (corneal limbus) during vitreoret...
Electronic micropipette
A device that is typically hand-held and used in the laboratory to withdraw, transfer, and inject minute volumes of fluid materials (e.g., microlitres or smaller). This device is electronically operated and can have a single channel or a multichannel piston...
Mechanical micropipette
A manually-operated device typically used in the laboratory to withdraw, transfer, and inject minute volumes of fluid materials (e.g., microlitres or smaller). The device is typically hand-held and operates through an internal mechanism powered by finger de...
Clinical laboratory analyser/instrument control unit IVD
An electrically-powered device intended to be used to control one or multiple in vitro diagnostic laboratory analyser(s)/instrument(s) used in the processing/preparation/analysis of a clinical specimen. It is designed to enable the user to input/manipulate ...
Pressure-wave skin contouring system
An assembly of devices using extracorporeal pulse activation technology (EPAT) and designed for acoustic wave treatment (AWT) intended primarily to reduce the appearance of cellulite through mobilization of free fatty acids and oxidative agents in tissue. I...
Vitrectomy sutureless lens holding ring, single-use
A sterile device in the form of a small circular ring designed to contain a selected vitrectomy sutureless lens (VSL) within its confines to hold the lens in the correct position directly to the front surface of the eye (corneal limbus) during vitreoretinal...
Electronic pipette, multifunction
A device typically used in the laboratory to withdraw, transfer, and inject specific volumes of fluid materials. It is electronically operated and can have a single channel or a multichannel piston/cylinder pick up assembly. The device delivers the same vol...
Magnetic cell separation reagent IVD
An in vitro diagnostic substance or reactant intended to selectively bind one or more specific epitopes expressed by cells in heterogeneous human cell preparations for the subsequent magnetic separation of a target cell population. It typically consists of ...
CD62L cell marker 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 CD62L cell marker, also known as L-selectin, in a clinical specimen.
CD62P cell marker 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 CD62P cell marker, also known as P-selectin, in a clinical specimen.
Magnetic cell separation system reagent
A sterile device that is a component of a magnetic cell separation system intended to selectively bind one or more specific epitopes expressed by cells in heterogeneous human cell preparations for the subsequent magnetic separation of a target cell populati...