A collection of reagents intended to be used for tissue processing in a histology laboratory to prepare biological tissues or clinical tissue specimens for embedding, or related procedures, by successively removing water and alcohol. It may consist of a fix...
An assembly of devices designed for the automated processing of blood, relative components or cellular products (e.g., umbilical cord blood, bone marrow), in a closed sterile environment using centrifugation to isolate constituent components (e.g., cells, p...
A collection of sterile devices that is a component of a blood centrifugation system intended to be used during the centrifugation of blood, relative components or cellular products (e.g., umbilical cord blood, bone marrow), to automatically isolate constit...
A collection of reagents and other associated materials intended to be used alone or in combination with other IVDs for the liquefaction, digestion, and/or decontamination of a sputum specimen suspected of containing microorganisms associated with respirato...
A pouch, unit, and/or other accessories intended to be used in combination to generate specific atmospheric conditions [e.g., increased carbon dioxide (CO2), reduced or depleted oxygen (AnO2)] as an environment suitable for the cultivation, processing, or t...
A collection of reagents and other associated materials intended to be used to calibrate or verify the performance of a polymerase chain reaction (PCR) analyser to ensure its proper function prior to analysis/processing of clinical samples.
A coloured solution intended to be used to permanently mark the surgical margins and/or other general areas of interest on a tissue biopsy specimen; it is not intended to stain a tissue section for the visualization of intra/extracellular elements. It is on...
A collection of sterile devices designed to disaggregate cells from a split-thickness skin biopsy for immediate application to a prepared wound bed in the donor patient (skin cell autograft) to promote healing and skin cover. It typically includes a process...
A collection of reagents and other associated materials intended to be used to calibrate or verify the performance of a mass spectrometry analyser to ensure its proper function, prior to analysis/processing of clinical samples.
A collection of reagents and other associated materials of known characteristics intended to be used to calibrate or verify the performance of a thermal cycler nucleic acid instrument/analyser [e.g., real-time polymerase chain reaction (PCR) machine] to ens...