Other kg 5

38.22 Diagnostic or laboratory reagents on a backing, prepared diagnostic or laborato reagents whether or not on a backing, other than those of beading 30.02 or 30.0g certified reference materials. This heading covers dia nostic or laboratory reagents on a backing, repared diagnostic or laboratory reagents, ot er than hagnostic reagents of heading 30.0 or diagnostic rea ents designed to be administered to the patient and blood grouping reagents of heading 30.0 . It also covers certified reference materials. Diagnostic reagents are used in the evaluation of physical, biophysical or biochemical processes and states in animals and humans; their function is based upon a measurable or observable change in the biological or chemical substances constituting the reagent. Prepared diagnostic reagents of this headmg may be similar in function to those desi ed to be admnistered to atients (subheading 3006.30), with the exception that the are use for in vitro, rather than or in vivo, applications. Prepared laboratory reagents inc ude not only diagnostic rea ents, but also other analytical reagents used for p oses other than detection or hagnosis. kepared dia ostic and laboratory reagents m y"ge used in medical, veterin scientific or industrial la oratories, in hospitals, in industry, in the field or, in some cases, in e home. 'J % r r i f C T Reagents of this heading are either on a backing or in the form of pre arations and thus comprise more than a single constituent. For exam leythey may consist of a xtures of two or more reagents or of single reagents dissolved in so vents other than water. They may also be in the form of paper, plastics or other materials (used as backin s or supporth impre$-ated. or coated with one or more diagnostic or laboratory reagents, suci? as litmus, p or po e fmding apers or pre-coated immuno-assa plates. Reagents of this heading may also be put up in the Form of luts, consisting of severa components, even if one or more components are separate chemically defined compounds of Cha ter 28 or Chapter 29, synthetic colouring matter of heading 32.04 or any other substance w ich, when presented separately, would be classifiable under another headin . Examples of such kits are those for testin glucose in blood, ketones in urine, etc., and those ased on enzymes. However, diagnostic kits aving the essential character of roducts of heading 30.02 or 30.06 (e.g., those based on monoclonal or polyclonal anti odies) are excluded. S, P Y E E % ! The reagents of this heading should be clearly identifiable as being for use only as diagnostic or laborato reagents. This must be clear from their composition, labelling, instructions for in vitro or aboratory use, indication of the specific diagnostic test to be performed or physical form (e.g., presented on a backing or support). With the exception of the products of Chapter 28 or 29, for the classification of certified reference materials, heading 38.22 shall take precedence over any other heading in the Nomenclature. The certified reference materials of this heading are reference materials prepared for the calibration of an ap aratus, the assessment of a measurement method or the assignment of values to a material. hese reference materials may consist of the following : f (a) Substrate materials containing added analytes, the concentration of which has been accurately determined; (b) Unmixed materials, the concentration of certain components of which has been accurately determined (e.g., the protein and fat content of milk powder); (c) Materials, whether natural or s thetic, certain roperties of which have been accurately determined (e.g., tensile strenxspecific gravid. These reference materials must be accom anied by a certificate which indicates the values of the certified properties, the methods use& determine the values and the degree of certainty associated with each value, and the certifying authority. The heading also excludes the following reagents, whether or not put up in forms for use as diagnostic or laboratory reagents : (a) Goods of headings 28.43 to 28.46 and 28.52 (see Note 1 to Section VI); @) Products covered by Note 1 to Chapter 28 or Note 1 to Chapter 29; (c) Colouring matter of heading 32.04, including preparations mentioned in Note 3 to Chapter 32; (d) Pr ared culture media for the development or maintenance of micro-organisms (including viruses an?k like) or of plant, human or animal cells (heading 38.21).