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I.S. EN 12376:1999

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Available format(s)

Hardcopy , PDF

Superseded date

05-02-2013

Language(s)

English

Published date

01-01-1999

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

Defines requirements for information supplied by the manufacturer with reagents used in staining in biology.

DocumentType
Standard
Pages
22
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

Standards Relationship
BS EN 12376:1999 Identical
SN EN 12376 : 1999 Identical
NF EN 12376 : 1999 Identical
NBN EN 12376 : 1999 Identical
UNE-EN 12376:1999 Identical
NEN EN 12376 : 1999 Identical
UNI EN 12376 : 2001 Identical
EN 12376:1999 Identical
NS EN 12376 : 1ED 1999 Identical

EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE

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