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What is a medical device? According to Section 2 of Act 737, “medical device” means any instrument, apparatus, implement, machine, appliance, implant, in ,vitro, reagent or calibrator, software, material or other similar or related article: a. intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose (s) of;
For in ,vitro diagnostic, use only. Dispose of patient samples and all materials used to perform this test as if they contain infectious agents. Do not mix reagents or coated microtiterstrips from ,kits, with different lot numbers. Chromogen Solution contains the hazardous ingredient N-Methyl-2-pyrrolidone at a concentration > 0,3 %.
POCT test ,kits, refer to various ,diagnostic, test ,kits, that can be performed on the scene of caring, i.e. the lateral flow immunoassay, colloidal gold filtration test, and Dot-ELISA ,kits,; ELISA reagent ,kits,, refer to the enzyme-linked immunosorbent assay test ,kits,, which can be used in laboratories with full set of equipment such as plate washer, plate reader, incubator.
Test ,Kits, for In-,Vitro, Diagnosis (IVD) In-,Vitro, Diagnosis (IVD) refers to a series of assay methods, in which human blood, urine or secretion specimens etc. are tested outside of the human body, so as to find the clinical proof of certain health conditions such as virus infection, diseases, damage to certain organ.
FOR IN ,VITRO DIAGNOSTIC, USE CONTENTS INTENDED USE ... ,PRINCIPLE, OF THE PROCEDURE ... Process Buffer 16 tubes/,kit, 1.45 mL 2°C to 30°C Reaction Tubes 16 tubes/,kit, 2°C to 8°C Amplicon Cartridge 16/,kit, 2°C to 30°C MATERIALS REQUIRED BUT NOT PROVIDED ...
In ,vitro diagnostic, (IVD) medical devices are test ,kits, and instrumentation used to test human samples to assist clinical diagnosis or decisions concerning clinical management. A European Union directive published in 1998  (the ‘IVD Directive’) gives definitions for: a medical device; an in ,vitro diagnostic, medical device (see
Principles of In Vitro Diagnostic, (IVD) Medical Devices Classification. Authoring Group: IMDRF IVD Working Group . ... accessory for an in ,vitro diagnostic, medical device’ means an article which, ... an instrument that is specifically required to perform a particular test will be assessed at the same time as the test ,kit,.
material, ,kit,, instrument, apparatus, equipment or system, that is intended by its product owner to be used in ,vitro, for the examination of any specimen, including any blood or tissue donation, derived from the human body, solely or principally for the purpose of providing information —
Guiding ,Principle, for the Instructions ,of In Vitro Diagnostic, Reagents The instruction ,of In vitro diagnostic, reagents includes intended use, inspection methods, and explanation for inspection consequence, cautions, and other important information. The instruction is important technical document to guide operators to use properly and