Shanghai Sunland Industrial Co., Ltd is the top manufacturer of Personal Protect Equipment in China, with 20 years’experience. We are the Chinese government appointed manufacturer for government power,personal protection equipment , medical instruments,construction industry, etc. All the products get the CE, ANSI and related Industry Certificates. All our safety helmets use the top-quality raw material without any recycling material.
Bank workers wear protective clothing
We provide exclusive customization of the products logo, using advanced printing technology and technology, not suitable for fading, solid and firm, scratch-proof and anti-smashing, and suitable for various scenes such as construction, mining, warehouse, inspection, etc. Our goal is to satisfy your needs. Demand, do your best.
Professional team work and production line which can make nice quality in short time.
The professional team provides 24 * 7 after-sales service for you, which can help you solve any problems
In ,vitro diagnostics, (IVDs) test a sample of tissue or bodily fluid in an effort to diagnose a disease or condition. Effectively used, IVDs help to reduce hospital stays, support patients to look after their own health and release resources for use elsewhere in the NHS, resulting in a healthier population and stronger economic growth.
In ,vitro diagnostic kits, often have very simple readouts, such as an indicator that gives a “yes or no” answer. This makes it easier for the clinician to process the information and record the information in the form of a photocopy, a scanned image, or a simple written notation of “positive” or “negative.”
According to the In-,Vitro Diagnostic, Device Directive IVDD 98/79/EC an 'in-,vitro diagnostic, medical device` is defined as any medical device which is a reagent, reagent product, calibrator, control material, ,kit,, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in-,vitro, for the examination of specimens, including blood ...
Health care providers rely on a variety of tools to diagnose conditions and guide treatment decisions. Among the most common and widely used are in ,vitro diagnostics, (IVDs), which are clinical tests that analyze samples taken from the human body. Patients may receive—or forgo—medical care based on ,diagnostic, test results, making it critically important that tests are reliable.
Assays and ,kits, that enable clinical laboratories to create and deploy next-generation sequencing-based molecular ,diagnostic, tests. ... The MiSeqDx instrument is the first FDA-cleared in ,vitro diagnostic, (IVD) next-generation sequencing (NGS) system. Learn More.
The concept of an in ,vitro diagnostic kit, has become increasingly relevant in discussions related to the revision of the IVD Directive; therefore EDMA aims to set a common ground for the perception and terminology of such an IVD medical device. Posted on 20.10.2015. Share this page.
In ,Vitro Diagnostic, Medical Device Performance Evaluation: 8 Steps to Conformity. Tuesday, May 5, 2020. If manufacturers don’t conduct a legally compliant performance evaluation of their in ,vitro diagnostic, medical device (IVD), they aren’t just running the risk of problems during the authorization process.. They are risking patient safety.
CE Marking is required for all in ,vitro diagnostic, (IVD) devices sold in Europe.CE Marking indicates that an IVD device complies with the European In-,Vitro Diagnostic, Devices Directive (98/79/EC) and that the device may be legally commercialized in the EU.
In ,Vitro Diagnostic, Medical Device: ‘In ,Vitro Diagnostic, Medical Device’ means any medical device which is a reagent, reagent product, calibrator, control material, ,kit,, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in ,vitro, for the examination of specimens, including blood and tissue donations , derived from the ...
IVD ,kits, are set of components packaged together and intended to be used for, or part thereof, for a specific in ,vitro diagnostic, examination. Covid-19 antibody detection ,kit, is intended for the detection of 2019-Novel Coronavirus antibody in serum of patients or suspected cases.