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The WHO model list of essential in vitro diagnostics, or WHO list of essential diagnostic tests (EDL) is a World Health Organization (WHO) priority list of medical tests that provides guidance for individual countries on which tests to use and which not to.
Part 2-081: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes; Part 2-091: Particular requirements for cabinet X-ray systems; Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment; Part 2-202: Particular requirements for electrically operated valve actuators
Laboratory-developed tests (LDTs) are a class of in vitro diagnostics (IVDs) designed, manufactured, and used within a single laboratory. They are employed for various medical diagnoses and research applications, offering advantages in flexibility and fostering innovation in the diagnostics field. [2]
ISO 19001:2013 In vitro diagnostic medical devices – Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology; ISO 19005 Document management – Electronic document file format for long-term preservation
Instrument Uses Test tube: Folin-Wu tube: Glass slide mycole and cover slips: in microscopy, serology, etc. as the solid backing on which test samples are : Petri dish: used for preparation of culture media and the culture of organisms they are in
Ortho Clinical Diagnostics (now QuidelOrtho) is an in vitro diagnostics company that made products and diagnostic equipment for blood testing.Ortho served two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion ...
used for fine needle aspiration of material from inside the body; used for diagnostic examinations of the cells hence obtained; video link: Trephine biopsy needle [4] used for taking a biopsy from a deep hard tissue like bone marrow (within a hard bone) Spirometer: used to test lung function; video link •Water-seal type-do- •Douglas bag ...
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.