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What would be the use of immortality to a person who cannot use well a half an hour? - Ralph Waldo Emerson
    A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use. It must be intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state, a congenital abnormality or to determine safety and compatibility with a potential recipient, or to monitor therapeutic measures.

    The definition of an IVD does not encompass products that are intended for general laboratory use that are not manufactured, sold or presented for use specifically as an IVD.

    ‘Medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of :
    • diagnosis, prevention, monitoring, treatment or alleviation of disease
    • diagnosis, monitoring, treatment, alleviation, or compensation for an injury or handicap
    • investigation, replacement or modification of the anatomy or of a physiological process
    • control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”

  2. Why certification for in vitro diagnosis ?

  3. which product go for in vitro diagnosis?
    This directive, along with two associated directives, the Active Implantable Medical Devices Directive and the In Vitro Diagnostic Devices Directive, cover all medical equipment.

    This directive includes equipment intended by the manufacturer to be used to diagnose, prevent, monitor, treat, alleviate, compensate for and/or control a disease, injury, handicap, physiological process or conception. This directive excludes any products which come under the scope of one of the other two medical directives

  4. Step to achieve in vitro diagnosis

  5. What are the advantage of in vitro diagnosis ?

  6. Important link for in vitro diagnosis
  7. Downloads & images

  8. Please email us on customer.care@netpeckers.net for further details
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