DIN EN 12376:1999-04
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY
Hardcopy , PDF
01-07-2013
English
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
3.1 Information supplied by the manufacturer
3.2 Label
3.3 In vitro diagnostic
3.4 Staining
3.5 Dye
3.6 Stain
3.6.1 Stock solution of stain
3.7 Chromogenic reagent
3.8 Fluorochrome
3.9 Antibody
3.9.1 Polyclonal antibody
3.9.2 Monoclonal antibody
3.10 Nucleic acid probe
3.11 Lectin
4 Requirements for information supplied by the manufacturer
4.1 General requirements
4.1.1 Information supplied by the manufacturer
with reagents used for staining in biology
4.1.2 Product name
4.1.3 Description of reagent
4.1.4 Intended use
4.2 Additional requirements for specific kinds of
reagents
4.2.1 Fluorochromes
4.2.2 Metal salts
4.2.3 Antibodies
4.2.4 Nucleic acid probes
Annex A (informative) Examples of information supplied by
the manufacturer with reagents commonly used in biological
staining procedures
A.1 Methyl Green-Pyronin Y stain
A.2 Feulgen-Schiff reaction
A.3 Immunohistochemical demonstration of oestrogen
receptors
A.4 Flow cytometric demonstration of T-cells
Annex B (informative) Bibliography
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