CLSI C28 A2 : 2ED 2000

Withdrawn

Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY

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Withdrawn date: 24-11-2008

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Published date: 12-01-2013

Publisher: Clinical Laboratory Standards Institute

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Gives guidelines for determining reference intervals to meet minimum reliability and usefulness requirements. Covers health-associated reference values with relation to quantitative clinical laboratory tests. Includes various study requirements for the determination of reference values for new analyte or a new analytical method of a previously measured analyte.

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Development Note	Supersedes NCCLS C28 A (03/2001)
Document Type	Miscellaneous Product
ISBN
Pages
Published
Publisher	Clinical Laboratory Standards Institute
Status	Withdrawn
Supersedes	CLSI C28 A : 1995

Standards Referenced By This Book - (Show below) - (Hide below)

BS EN ISO 18113-2:2011	In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use
CLSI GP29 A2 : 2ED 2008	ASSESSMENT OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE
DIN EN ISO 18113-4:2013-01	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)
CLSI H42 A2 : 2ED 2007	ENUMERATION OF IMMUNOLOGICALLY DEFINED CELL POPULATIONS BY FLOW CYTOMETRY
CLSI H54 A : 1ED 2005	PROCEDURES FOR VALIDATION OF INR AND LOCAL CALIBRATION OF PT/INR SYSTEMS
CLSI H45 A2 : 2ED 2005	PERFORMANCE OF THE BLEEDING TIME TEST
BS EN ISO 18113-4:2011	In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing
UNE-EN ISO 18113-2:2012	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
UNI EN ISO 18113-4 : 2012	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
CLSI H21 A5 : 5ED 2008	COLLECTION, TRANSPORT, AND PROCESSING OF BLOOD SPECIMENS FOR TESTING PLASMA-BASED COAGULATION ASSAYS AND MOLECULAR HEMOSTASIS ASSAYS
CLSI I/LA2 A2 : 2ED 2006	QUALITY ASSURANCE OF LABORATORY TESTS FOR AUTOANTIBODIES TO NUCLEAR ANTIGENS: (1) INDIRECT FLUORESCENCE ASSAY FOR MICROSCOPY AND (2) MICROTITER ENZYME IMMUNOASSAY METHODS
CLSI H57 A : 1ED 2008	PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
UNE-EN ISO 18113-4:2012	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
UNE-EN ISO 18113-1:2012	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
DIN EN ISO 18113-2:2013-01	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
CLSI EP15 A2 : 2ED 2006	USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
CLSI H57 P : 1ED 2007	PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
UNI EN ISO 18113-2 : 2012	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
I.S. EN ISO 18113-1:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
I.S. EN ISO 18113-4:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)
ISO 18113-2:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
BS EN 13612:2002	Performance evaluation of in vitro diagnostic medical devices
ISO 18113-4:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
ISO 18113-1:2009	In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
EN ISO 18113-1:2011	In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
EN 13612:2002/AC:2002	PERFORMANCE EVALUATION OF IN VITRO DIAGNOSTIC MEDICAL DEVICES
DIN EN ISO 18113-1:2013-01	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
BS EN ISO 18113-1:2011	In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
I.S. EN ISO 18113-2:2011	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
UNI EN ISO 18113-1 : 2012	IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS

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