A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some...
A collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories (e.g., gloves, drapes, tray) intended for self-urinary catheterization. The catheter may be repeatedly inserted through ...
A collection of devices intended to be used for carbon-13 breath analysis to investigate suspected gastrointestinal disorders [e.g., gastric emptying disorder (gastroparesis), H. pylori infection]. It consists of an ingestible carbon-13 labelled substrate a...
A collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit ma...
A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique ...
A collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis,...
A collection of devices and materials intended to be used by a healthcare professional at the point-of-care to collect a dried blood spot (DBS) specimen from capillary or venous blood, for subsequent diagnostic testing or screening. The kit typically includ...
A collection of items intended to be used for the collection of a clinical specimen at home, and its subsequent transport to a remote clinical laboratory for diagnostic testing. The kit includes a specimen container, instructions for use, a test order form,...
A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a rectal/faecal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit co...
A collection of non-sterile items intended to be used for the collection of a clinical specimen at home, and its subsequent transport to a remote clinical laboratory for diagnostic testing. The kit includes a specimen container, instructions for use, a test...
A collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis,...
A collection of in vitro diagnostic devices and materials intended for use by a healthcare professional at the point-of-care for the collection of a venous blood specimen, for subsequent diagnostic testing or screening. The kit typically includes venous acc...
A collection of devices intended to be used for the collection, preservation, and transport of any type of clinical specimen (e.g., faeces, sputum, mucous, wound exudate, vaginal secretion) collected from any body part [e.g., natural orifice, skin (i.e., it...
A collection of in vitro diagnostic devices and materials intended to be used by a layperson in the home to collect a semen specimen for subsequent in vitro diagnostic investigations (e.g., fertility testing). The kit typically includes a covered specimen r...
A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and oth...
A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and oth...
A collection of devices intended to be used to efficiently clean and prepare an operating room (OR) for a subsequent surgical procedure. It typically includes patient oriented items such as absorbent covers/drapes for the operating table and patient positio...
A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent,...
A collection of reagents and other associated materials intended to be used for the discrete visualisation of immune complexes bound to specific cellular markers in a clinical specimen. Sustrates are used to detect immunoperoxidase-bound complexes and may i...
A sterile implantable device consisting of demineralized bone matrix (DBM) processed from cadaveric human bone (allograft) and mixed with bioabsorbable synthetic minerals (e.g., calcium phosphate), intended to fill bony voids or gaps in the skeletal system ...
A collection of non-sterile devices intended to be used for the manual irrigation, washing, and evacuation of debris (toxic substances) from the stomach. It typically consists of supply/drain bags with lavage and ancillary tubing; activated charcoal may be ...
A collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or to verify the absence of i...
A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes acrylic resin material (without hardening fillers/materials) and additional materials to support restoration (e....
A collection of chemical agents, dyes and/or solutions intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen for subsequent visualization, examinati...
A collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoe...
A collection of sterile devices designed to be used for the biochemical preparation and subsequent delivery of autologous fibrin sealant to a site of intervention during an endoscopic surgical procedure (e.g., to achieve haemostasis, seal air leaks, adhere ...
A collection of sterile devices and reagent solution intended to be used in vitro with an ultraviolet (UV) blood illuminator for photochemical treatment of donor blood (including whole blood, plasma, and/or platelet concentrates) to inactivate blood transfu...
A collection of devices intended to be used for the separation through filtration and collection of plasma from a whole blood specimen for subsequent in vitro diagnostic investigation. It typically consists of a contained or encased selectively-permeable me...
A collection of sterile devices, including a fluid or semifluid substance, used in combination to replace the fluid of the eye. This is a single-use device.
A collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or ribonucleic acid (RNA), an...