|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Extent of Recognition
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Standard Title (click for recognition information)
|
08/20/2012 |
InVitro Diagnostics |
7-148 |
Complete |
CLSI |
M28-A2 (Replaces M28-A) |
Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition. |
12/19/2022 |
InVitro Diagnostics |
7-313 |
Complete |
CLSI |
EP27 2nd Edition |
Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures |
08/21/2017 |
InVitro Diagnostics |
7-273 |
Complete |
CLSI |
M58 1st Edition |
Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry |
07/09/2014 |
InVitro Diagnostics |
7-175 |
Complete |
CLSI |
C59-A |
Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline |
08/21/2017 |
InVitro Diagnostics |
7-270 |
Complete |
CLSI |
I/LA-20 3rd Edition (Replaces I/LA20-A3) |
Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities |
08/14/2015 |
InVitro Diagnostics |
7-253 |
Complete |
CLSI |
EP15-A3 (Reaffirmed: September 2019) |
User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition |
12/18/2023 |
InVitro Diagnostics |
7-318 |
Complete |
CLSI |
EP25 2nd Edition |
Evaluation of Stability of In Vitro Medical Laboratory Test Reagents |
03/18/2009 |
InVitro Diagnostics |
7-170 |
Complete |
CLSI |
I/LA21-A2 |
Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition |
03/18/2009 |
InVitro Diagnostics |
7-176 |
Complete |
CLSI |
I/LA30-A (Replaces I/LA30-P) |
Immunoassay Interference by Endogenous Antibodies; Approved Guideline. |
04/04/2016 |
InVitro Diagnostics |
7-260 |
Complete |
CLSI |
MM03-3rd Edition (Replaces MM03-A2) |
Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline |
09/17/2018 |
InVitro Diagnostics |
7-284 |
Complete |
CLSI |
EP37 1st Edition |
Supplemental Tables for Interference Testing in Clinical Chemistry |
09/17/2018 |
InVitro Diagnostics |
7-277 |
Complete |
CLSI |
GP41 7th Edition |
Collection of Diagnostic Venous Blood Specimens |
09/17/2018 |
InVitro Diagnostics |
7-278 |
Complete |
CLSI |
M27 4th Edition |
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts |
09/17/2018 |
InVitro Diagnostics |
7-279 |
Complete |
CLSI |
M07 11th Edition |
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically |
09/17/2018 |
InVitro Diagnostics |
7-280 |
Complete |
CLSI |
M02 13th Edition |
Performance Standards for Antimicrobial Disk Susceptibility Tests |
01/30/2014 |
InVitro Diagnostics |
7-152 |
Complete |
CLSI |
EP12-A2 |
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition. |
03/18/2009 |
InVitro Diagnostics |
7-145 |
Complete |
CLSI |
H42-A2 (Replaces H42-A) |
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition. |
01/30/2014 |
InVitro Diagnostics |
7-244 |
Complete |
CLSI |
NBS01-A6 (Replaces LA04-A5) |
Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition |
08/20/2012 |
InVitro Diagnostics |
7-197 |
Complete |
CLSI |
M35-A2 (Replaces M35-A) |
Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition. |
08/20/2012 |
InVitro Diagnostics |
7-76 |
Complete |
CLSI |
M15-A (Replaces M15-T) |
Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline |
03/16/2012 |
InVitro Diagnostics |
7-165 |
Complete |
CLSI |
H20-A2 (Replaces H20-A) |
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition |
03/16/2012 |
InVitro Diagnostics |
7-166 |
Complete |
CLSI |
GP20-A2 (Replaces GP20-A) |
Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition |
03/16/2012 |
InVitro Diagnostics |
7-225 |
Complete |
CLSI |
GP34-A (Replaces GP34-P) |
Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance |
08/02/2011 |
InVitro Diagnostics |
7-219 |
Complete |
CLSI |
I/LA28-A2 |
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition. |
01/30/2014 |
InVitro Diagnostics |
7-224 |
Complete |
CLSI |
EP28-A3c (Formerly C28-A3c) |
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition |
01/30/2014 |
InVitro Diagnostics |
7-223 |
Complete |
CLSI |
QMS06-A3 (Formerly GP22-A3) |
Quality Management System: Continual Improvement; Approved Guideline - Third Edition |
05/29/2023 |
InVitro Diagnostics |
7-315 |
Complete |
CLSI |
EP12 3rd Edition |
Evaluation of Qualitative, Binary Output Examination Performance |
12/18/2023 |
InVitro Diagnostics |
7-319 |
Complete |
CLSI |
M23 6th Edition |
Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters |
12/21/2020 |
InVitro Diagnostics |
7-304 |
Complete |
CLSI |
M23 5th Edition |
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters |
11/08/2005 |
InVitro Diagnostics |
7-113 |
Complete |
CLSI |
I/LA23-A (Replaces I/LA23-P) |
Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline |
03/16/2012 |
InVitro Diagnostics |
7-150 |
Complete |
CLSI |
H43-A2 |
Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition |
09/09/2008 |
InVitro Diagnostics |
7-21 |
Complete |
CLSI |
C42-A |
Erythrocyte Protoporphyrin Testing; Approved Guideline |
09/09/2008 |
InVitro Diagnostics |
7-136 |
Complete |
CLSI |
I/LA2-A2 (Replaces I/LA2-A) |
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition. |
09/09/2008 |
InVitro Diagnostics |
7-159 |
Complete |
CLSI |
H21-A5 |
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays |
01/15/2013 |
InVitro Diagnostics |
7-235 |
Complete |
CLSI |
EP25-A (Replaces EP25-P) |
Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. |
08/14/2015 |
InVitro Diagnostics |
7-251 |
Complete |
CLSI |
EP05-A3 (Reaffirmed: September 2019) |
Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition |
08/06/2013 |
InVitro Diagnostics |
7-242 |
Complete |
CLSI |
C56-A |
Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline |
09/21/2016 |
InVitro Diagnostics |
7-266 |
Complete |
CLSI |
EP19 2nd Edition (Replaces EP19-R) |
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures |
09/09/2008 |
InVitro Diagnostics |
7-163 |
Complete |
CLSI |
H56-A (Replaces H56-P) |
Body Fluid Analysis for Cellular Composition; Approved Guideline. |
12/23/2019 |
InVitro Diagnostics |
7-295 |
Complete |
CLSI |
M52, 1st ed. August 2015 (Reaffirmed: January 2020) |
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems. |
09/17/2018 |
InVitro Diagnostics |
7-276 |
Complete |
CLSI |
M38 3rd Edition |
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi |
08/14/2015 |
InVitro Diagnostics |
7-257 |
Complete |
CLSI |
M56-A |
Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline |
09/17/2018 |
InVitro Diagnostics |
7-283 |
Complete |
CLSI |
POCT04 3rd Edition |
Essential Tools for Implementation and Management of a Point-of-Care Testing Program |
09/17/2018 |
InVitro Diagnostics |
7-275 |
Complete |
CLSI |
EP07 3rd Edition |
Interference Testing in Clinical Chemistry. |
05/29/2023 |
InVitro Diagnostics |
7-316 |
Complete |
CLSI |
NBS01 7th Edition |
Dried Blood Spot Specimen Collection for Newborn Screening |
07/15/2019 |
InVitro Diagnostics |
7-288 |
Complete |
CLSI |
M24 3rd Edition |
Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes |
10/04/2004 |
InVitro Diagnostics |
7-104 |
Complete |
CLSI |
H7-A3 |
Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition. |
03/18/2009 |
InVitro Diagnostics |
7-189 |
Complete |
CLSI |
M47-A (Replaces M47-P) |
Principles and Procedures for Blood Cultures; Approved Guideline |
03/18/2009 |
InVitro Diagnostics |
7-190 |
Complete |
CLSI |
M50-A (Replaces M50-P) |
Quality Control for Commercial Microbial Identification Systems; Approved Guideline |
03/18/2009 |
InVitro Diagnostics |
7-192 |
Complete |
CLSI |
MM18-A (Replaces MM18-P) |
Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline |