Medical diagnostic kits

Although soluble polymers have been investigated as supports [28, 29] they tend to bring with them separation problems which can be overcome, e.g. by micro- or ultra-filtration, but not conveniently so. On the other hand macroscopic polymeric objects have not been well investigated in this context, because they are not convenient for use in small laboratory-scale reactors and unless well designed are likely to offer only very low capacities. In contrast, however, macroscopic polymeric supports have proved invaluable for the immobilisation of reactive biomolecules and now form the basis of many domestic as well as clinical medical diagnostic kits [30]. 

These guidelines are designed for procurement of pharmaceutical products. They may also be applicable to the procurement of diagnostic kits or medical devices. 

Avidin was the first commercially available recombinant protein (1997) to be derived from a transgenic system (corn seed) for use in medical applications [285, 286, 291]. As it forms strong, non-covalent bonds with biotin, avidin is used in medical and biochemical diagnostic kits for the detection of biotin-containing proteins and nucleic acids. Transgenic corn which accumulated avidin was developed jointly by... 

The sampling kit consists of the labelled urea, which is a drug a sampling straw, which is a device and a sample container, which would be considered an in-vitro diagnostic (IVD) medical device under EU definitions. Other examples of diagnostic drug products used in conjunction with medical devices include dyes administered to visualise blocked veins and arteries. 

Instrnments, kits, or test systems labeled for research use only or for investigational nse only have not been cleared by the United States Food and Drng Administration for sale to diagnose disease or other conditions. These products cannot be nsed as a diagnostic tool unless diagnosis is confirmed with a medically accepted test or procednre. Therefore, the laboratory mnst clearly state in the report that the test resnlts are not to be nsed for diagnostic or treatment purposes. 

The term medical device is defined under section 2 of the Medicines Act 1981 and includes any device, instrument or apparatus (or its component parts) which is used principally in humans for a therapeutic purpose. It includes bandages and in vitro diagnostic agents. It should be noted that a number of products are defined as medicines in New Zealand which in other countries are controlled as medical devices (e.g., pregnancy test kits). 

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