Crosswalk of Documents Referenced Within FDA Accreditation Checklists
The US FDA identifies voluntary consensus standards for which they will accept a declaration of conformity validating that the manufacturer has met relevant requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA may recognize all, part, or none of a standard established by a national or international SDO. This crosswalk provides a quick reference to those CLSI clinical and laboratory standards recognized by the FDA.
If there are any discrepancies between the FDA-Recognized Consensus Standards and the FDA-Recognized Consensus Standards Database, the FDA database should be regarded as the definitive source.
(Note: CLSI standards and guidelines can be located in the FDA database by searching on “CLSI” and/or “NCCLS.”)
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Product Code
|
Former Code
|
DL Title
|
Specialty Task Group
|
Date of Recognition
|
Recognition Number
|
Type of Recognition
|
Publication Date
|
Product Status
|
---|---|---|---|---|---|---|---|---|
AUTO02-A2
|
|
Laboratory Automation: Bar Codes for Specimen Container Identification
|
Software/Informatics
|
2008-09-09
|
13-9
|
Complete
|
2006-01-06
|
Archived
|
AUTO03-A2
|
|
Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems
|
Software/Informatics
|
2012-03-16
|
13-30
|
Complete
|
2009-09-30
|
Archived
|
AUTO04-A
|
|
Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements.
|
Software/Informatics
|
2008-09-09
|
13-12
|
Complete
|
2001-03-20
|
Archived
|
AUTO05-A
|
|
Laboratory Automation: Electromechanical Interfaces, 1st Edition
|
Software/Informatics
|
2008-09-09
|
13-13
|
Complete
|
2001-03-20
|
Archived
|
AUTO07-A
|
|
Laboratory Automation: Data Content for Specimen Identification
|
Software/Informatics
|
2013-08-06
|
13-37
|
Complete
|
2004-06-20
|
Archived
|
AUTO08-A
|
|
Managing and Validating Laboratory Information Systems
|
Software/Informatics
|
2009-03-18
|
13-25
|
Complete
|
2006-12-15
|
Archived
|
AUTO09-A
|
|
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet
|
Software/Informatics
|
2009-03-18
|
13-28
|
Complete
|
2006-03-22
|
Archived
|
AUTO10-A
|
|
Autoverification of Clinical Laboratory Test Results
|
Software/Informatics
|
2009-03-18
|
13-26
|
Complete
|
2006-10-31
|
Archived
|
AUTO11-A2
|
|
IT Security of In Vitro Diagnostic Instruments and Software Systems
|
Software/Informatics
|
2016-12-23
|
13-85
|
Complete
|
2014-10-31
|
Active
|
AUTO12-A
|
|
Specimen Labels: Content and Location, Fonts, and Label Orientation
|
Software/Informatics
|
2012-08-20
|
13-31
|
Complete
|
2011-04-28
|
Reaffirmed
|
AUTO13-A2
|
GP19-A2
|
Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring
|
Software/Informatics
|
2014-07-09
|
13-15
|
Complete
|
2003-02-18
|
Archived
|
C24-Ed4
|
C24-A3
|
Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
|
InVitro Diagnostics
|
2016-12-23
|
7-267
|
Complete
|
2016-09-29
|
Reaffirmed
|
C29-A2
|
C29-A
|
Standardization of Sodium and Potassium Ion-Selective Electrode Systems to the Flame Photometric Reference Method
|
InVitro Diagnostics
|
2004-03-08
|
7-86
|
Complete
|
2000-10-01
|
Archived
|
C31-A2
|
C31-A
|
Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling
|
InVitro Diagnostics
|
2004-03-08
|
7-87
|
Partial
|
2001-06-01
|
Archived
|
C34-Ed4
|
C34-A3
|
Sweat Testing: Sample Collection and Quantitative Chloride Analysis
|
InVitro Diagnostics
|
2020-12-21
|
7-302
|
Complete
|
2019-02-08
|
Active
|
C37-A
|
|
Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures
|
InVitro Diagnostics
|
2004-03-08
|
7-88
|
Complete
|
1999-11-01
|
Archived
|
C39-A
|
C39-P
|
A Designated Comparison Method for the Measurement of Ionized Calcium in Serum
|
InVitro Diagnostics
|
2004-03-08
|
7-89
|
Complete
|
2000-04-01
|
Archived
|
C42-A
|
|
Erythrocyte Protoporphyrin Testing
|
InVitro Diagnostics
|
2008-09-09
|
7-21
|
Complete
|
1996-01-11
|
Archived
|
C56-A
|
|
Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis
|
InVitro Diagnostics
|
2013-08-06
|
7-242
|
Complete
|
2012-07-13
|
Archived
|
C57-Ed1
|
|
Mass Spectrometry for Androgen and Estrogen Measurements in Serum
|
InVitro Diagnostics
|
2017-08-21
|
7-272
|
Partial
|
2015-02-27
|
Reaffirmed
|
C62-A
|
|
Liquid Chromatography-Mass Spectrometry Methods
|
InVitro Diagnostics
|
2016-09-21
|
7-265
|
Partial
|
2014-10-30
|
Replaced
|
EP05-A3
|
|
Evaluation of Precision of Quantitative Measurement Procedures
|
InVitro Diagnostics
|
2015-08-14
|
7-251
|
Complete
|
2014-10-01
|
Reaffirmed
|
EP06-Ed2
|
EP06-A
|
Evaluation of Linearity of Quantitative Measurement Procedures
|
InVitro Diagnostics
|
2021-06-07
|
7-306
|
Complete
|
2020-11-24
|
Active
|
EP07-Ed3
|
|
Interference Testing in Clinical Chemistry
|
InVitro Diagnostics
|
2018-09-17
|
7-275
|
Complete
|
2018-04-30
|
Reaffirmed
|
EP09-Ed3c
|
|
Measurement Procedure Comparison and Bias Estimation Using Patient Samples
|
InVitro Diagnostics
|
2020-07-06
|
7-296
|
Partial
|
2018-06-20
|
Active
|
EP12-Ed3
|
EP12-A2
|
Evaluation of Qualitative, Binary Output Examination Performance
|
InVitro Diagnostics
|
2023-05-29
|
7-315
|
Complete
|
2023-03-07
|
Active
|
EP14-A3
|
|
Evaluation of Commutability of Processed Sample
|
InVitro Diagnostics
|
2015-08-14
|
7-252
|
Complete
|
2014-08-15
|
Replaced
|
EP15-A3
|
|
User Verification of Precision and Estimation of Bias
|
InVitro Diagnostics
|
2015-08-14
|
7-253
|
Complete
|
2014-09-01
|
Reaffirmed
|
EP17-A2
|
|
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
|
InVitro Diagnostics
|
2013-01-15
|
7-233
|
Complete
|
2012-06-18
|
Reaffirmed
|
EP18-A2
|
|
Risk Management Techniques to Identify and Control Laboratory Error Sources
|
InVitro Diagnostics
|
2010-10-04
|
7-212
|
Complete
|
2009-11-30
|
Archived
|
EP-19-Ed2
|
EP19-A
|
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
|
InVitro Diagnostics
|
2016-09-21
|
7-266
|
Complete
|
2015-06-18
|
Replaced
|
EP21-Ed2
|
EP21-A
|
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures
|
InVitro Diagnostics
|
2016-12-23
|
7-268
|
Complete
|
2016-07-01
|
Active
|
EP24-A2
|
GP10-A
|
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves
|
InVitro Diagnostics
|
2013-08-06
|
7-234
|
Partial
|
2011-11-30
|
Reaffirmed
|
EP25-Ed2
|
EP21-A
|
Evaluation of Stability of In Vitro Medical Laboratory Test Reagents
|
InVitro Diagnostics
|
2023-12-18
|
7-318
|
Complete
|
2023-04-26
|
Active
|
EP27-Ed2
|
EP27-A
|
How to Construct and Interpret an Error Grid for Quantitative Measurement Procedures
|
InVitro Diagnostics
|
2022-12-19
|
7-313
|
Complete
|
2022-06-14
|
Active
|
EP28-A3c
|
C28-A3c
|
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory
|
InVitro Diagnostics
|
2014-01-30
|
7-224
|
Complete
|
2010-10-01
|
Reaffirmed
|
EP32-R
|
X05-R
|
Metrological Traceability and Its Implementation
|
InVitro Diagnostics
|
2014-01-30
|
7-239
|
Complete
|
2006-02-17
|
Active
|
EP34-Ed1
|
|
Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking
|
InVitro Diagnostics
|
2019-07-15
|
7-290
|
Partial
|
2018-08-13
|
Reaffirmed
|
EP35-Ed1
|
|
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures
|
InVitro Diagnostics
|
2020-07-06
|
7-298
|
Complete
|
2019-12-19
|
Active
|
EP37-Ed1
|
|
Supplemental Tables for Interference Testing in Clinical Chemistry
|
InVitro Diagnostics
|
2018-09-17
|
7-284
|
Complete
|
2018-04-30
|
Active
|
EP39-Ed1
|
|
A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests
|
InVitro Diagnostics
|
2021-12-20
|
7-311
|
Complete
|
2021-11-11
|
Active
|
GP16-A3
|
GP16-A2
|
Urinalysis
|
InVitro Diagnostics
|
2010-05-05
|
7-207
|
Complete
|
2009-02-05
|
Archived
|
GP20-A2
|
GP20-A
|
Fine Needle Aspiration Biopsy (FNAB) Techniques
|
InVitro Diagnostics
|
2012-03-16
|
7-166
|
Complete
|
2003-10-20
|
Archived
|
GP23-A2
|
GP23-A
|
Nongynecologic Cytologic Specimens: Collection and Cytopreparatory Technique
|
InVitro Diagnostics
|
2016-04-04
|
7-259
|
Partial
|
2014-11-24
|
Archived
|
GP34-A
|
GP34-P
|
Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection
|
InVitro Diagnostics
|
2012-03-16
|
7-225
|
Complete
|
2010-12-31
|
Reaffirmed
|
GP39-A6
|
H01-A6
|
Tubes and Additives for Venous and Capillary Blood Specimen Collection
|
InVitro Diagnostics
|
2014-07-09
|
7-221
|
Complete
|
2010-12-29
|
Archived
|
GP41-Ed7
|
|
Collection of Diagnostic Venous Blood Specimens
|
InVitro Diagnostics
|
2018-09-17
|
7-277
|
Complete
|
2017-04-15
|
Active
|
GP42-Ed7
|
GP42-A6
|
Collection of Capillary Blood Specimens
|
InVitro Diagnostics
|
2020-12-21
|
7-301
|
Complete
|
2020-09-16
|
Active
|
GP44-A4
|
GP44-A3
|
Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests
|
InVitro Diagnostics
|
2014-07-09
|
7-213
|
Complete
|
2010-05-25
|
Replaced
|
H07-A3
|
|
Procedure for Determining Packed Cell Volume by the Microhematocrit Method
|
InVitro Diagnostics
|
2004-10-04
|
7-104
|
Complete
|
2000-10-01
|
Archived
|
H15-A3
|
H15-A2
|
Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood
|
InVitro Diagnostics
|
2009-03-18
|
7-71
|
Complete
|
2000-12-01
|
Archived
|
H20-A2
|
H20-A
|
Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods
|
InVitro Diagnostics
|
2012-03-16
|
7-165
|
Complete
|
2007-01-18
|
Reaffirmed
|
H21-A5
|
|
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
|
InVitro Diagnostics
|
2008-09-09
|
7-159
|
Complete
|
2008-01-23
|
Active
|
H26-A2
|
|
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers
|
InVitro Diagnostics
|
2014-01-30
|
7-210
|
Partial
|
2010-06-25
|
Reaffirmed
|
H30-A2
|
|
Procedure for the Determination of Fibrinogen in Plasma
|
InVitro Diagnostics
|
2004-10-04
|
7-105
|
Complete
|
2001-11-01
|
Archived
|
H42-A2
|
H42-A
|
Enumeration of Immunologically Defined Cell Populations by Flow Cytometry
|
InVitro Diagnostics
|
2009-03-18
|
7-145
|
Complete
|
2007-05-22
|
Reaffirmed
|
H43-A2
|
|
Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells
|
InVitro Diagnostics
|
2012-03-16
|
7-150
|
Complete
|
2007-04-23
|
Reaffirmed
|
H47-A2
|
H47-A
|
One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test
|
InVitro Diagnostics
|
2010-05-05
|
7-205
|
Complete
|
2008-05-30
|
Replaced
|
H56-A
|
H56-P
|
Body Fluid Analysis for Cellular Composition
|
InVitro Diagnostics
|
2008-09-09
|
7-163
|
Complete
|
2006-07-10
|
Archived
|
H59-A
|
H59-P
|
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease
|
InVitro Diagnostics
|
2014-01-30
|
7-220
|
Partial
|
2011-03-31
|
Reaffirmed
|
H62-Ed1
|
|
Validation of Assays Performed by Flow Cytometry
|
InVitro Diagnostics
|
2023-12-18
|
7-320
|
Partial
|
2021-10-27
|
Active
|
I/LA02-A2
|
I/LA2-A
|
Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods
|
InVitro Diagnostics
|
2008-09-09
|
7-136
|
Complete
|
2006-03-22
|
Archived
|
I/LA20-Ed3
|
I/LA20-A3
|
Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies of Defined Allergen Specificities
|
InVitro Diagnostics
|
2017-08-21
|
7-270
|
Complete
|
2016-10-01
|
Active
|
I/LA21-A2
|
|
Clinical Evaluation of Immunoassays
|
InVitro Diagnostics
|
2009-03-18
|
7-170
|
Complete
|
2008-08-29
|
Archived
|
I/LA23-A
|
I/LA23-P
|
Assessing the Quality of Immunoassay Systems: Radioimmunoassays and Enzyme, Fluorescence, and Luminescence Immunoassays
|
InVitro Diagnostics
|
2005-11-08
|
7-113
|
|
2004-04-20
|
Archived
|
I/LA28-A2
|
|
Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays
|
InVitro Diagnostics
|
2011-08-02
|
7-219
|
Complete
|
2011-01-31
|
Reaffirmed
|
I/LA30-A
|
I/LA30-P
|
Immunoassay Interference by Endogenous Antibodies
|
InVitro Diagnostics
|
2009-03-18
|
7-176
|
Complete
|
2008-02-25
|
Archived
|
LIS01-A2
|
|
Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
|
Software/Informatics
|
2009-09-08
|
13-29
|
Complete
|
2008-04-28
|
Archived
|
LIS02-A2
|
|
Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems
|
Software/Informatics
|
2008-09-09
|
13-17
|
Complete
|
2004-10-20
|
Archived
|
M02-Ed13
|
M02-A12
|
Performance Standards for Antimicrobial Disk Susceptibility Tests
|
InVitro Diagnostics
|
2018-09-17
|
7-280
|
Complete
|
2018-01-18
|
Replaced
|
M07-Ed11
|
M07-A10
|
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
|
InVitro Diagnostics
|
2018-09-17
|
7-279
|
Complete
|
2018-01-11
|
Replaced
|
M11-Ed9
|
|
Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria
|
InVitro Diagnostics
|
2019-01-14
|
7-286
|
Complete
|
2018-10-16
|
Active
|
M15-A
|
M15-T
|
Laboratory Diagnosis of Blood-borne Parasitic Diseases
|
InVitro Diagnostics
|
2012-08-20
|
7-76
|
Complete
|
2000-06-01
|
Archived
|
M22-A3
|
M22-A2
|
Quality Control for Commercially Prepared Microbiological Culture Media
|
InVitro Diagnostics
|
2019-01-14
|
7-178
|
Complete
|
2004-06-20
|
Archived
|
M23-Ed6
|
|
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
|
InVitro Diagnostics
|
2023-12-18
|
7-319
|
Complete
|
2023-07-31
|
Active
|
M23-Ed5
|
|
Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
|
InVitro Diagnostics
|
2020-12-21
|
7-304
|
Complete
|
2018-01-16
|
Replaced
|
M24-Ed3
|
|
Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes
|
InVitro Diagnostics
|
2019-07-15
|
7-288
|
Complete
|
2018-11-28
|
Active
|
M27-Ed4
|
|
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
|
InVitro Diagnostics
|
2018-09-17
|
7-278
|
Complete
|
2017-11-30
|
Active
|
M27-M44-S-Ed3
|
|
Performance Standards for Antifungal Susceptibility Testing of Yeasts
|
InVitro Diagnostics
|
2022-12-19
|
7-314
|
Partial
|
2022-08-04
|
Active
|
M28-A2
|
M28-A
|
Procedures for the Recovery and Identification of Parasites From the Intestinal Tract
|
InVitro Diagnostics
|
2012-08-20
|
7-148
|
Complete
|
2005-06-30
|
Archived
|
M34-A
|
M24-P
|
Western Blot Assay for Antibodies to Borrelia burgdorferi
|
InVitro Diagnostics
|
2009-03-18
|
7-180
|
Complete
|
2000-10-01
|
Archived
|
M35-A2
|
M35-A
|
Abbreviated Identification of Bacteria and Yeast
|
InVitro Diagnostics
|
2012-08-20
|
7-197
|
Complete
|
2008-11-24
|
Reaffirmed
|
M36-A
|
|
Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii
|
InVitro Diagnostics
|
2009-03-18
|
7-182
|
Complete
|
2004-02-01
|
Archived
|
M38-Ed3
|
|
Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi
|
InVitro Diagnostics
|
2018-09-17
|
7-276
|
Complete
|
2017-11-30
|
Active
|
M39-Ed5
|
|
Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
|
InVitro Diagnostics
|
2022-05-30
|
7-312
|
Complete
|
2022-01-25
|
Active
|
M40-A2
|
|
Quality Control of Microbiological Transport Systems
|
InVitro Diagnostics
|
2015-01-27
|
7-250
|
Partial
|
2014-06-23
|
Reaffirmed
|
M41-A
|
|
Viral Culture
|
InVitro Diagnostics
|
2009-03-18
|
7-185
|
Complete
|
2006-11-30
|
Archived
|
M43-A
|
|
Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas
|
InVitro Diagnostics
|
2021-06-07
|
7-236
|
Partial
|
2011-10-27
|
Archived
|
M44-A2
|
|
Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts
|
InVitro Diagnostics
|
2019-07-15
|
7-287
|
Complete
|
2009-08-31
|
Replaced
|
M45-Ed3
|
|
Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
|
InVitro Diagnostics
|
2021-06-07
|
7-262
|
Partial
|
2015-10-02
|
Active
|
M47-A
|
|
Principles and Procedures for Blood Cultures
|
InVitro Diagnostics
|
2009-03-18
|
7-189
|
Complete
|
2007-05-24
|
Replaced
|
M48-Ed2
|
|
Laboratory Detection and Identification of Mycobacteria; Approved Guideline
|
InVitro Diagnostics
|
2019-01-14
|
7-285
|
Complete
|
2018-09-13
|
Active
|
M50-A
|
M50-P
|
Quality Control for Commercial Microbial Identification Systems
|
InVitro Diagnostics
|
2009-03-18
|
7-190
|
Complete
|
2008-08-29
|
Archived
|
M51-A
|
M51-P
|
Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi
|
InVitro Diagnostics
|
2013-08-06
|
7-243
|
Partial
|
2010-05-25
|
Archived
|
M52-Ed1
|
|
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems
|
InVitro Diagnostics
|
2019-12-23
|
7-295
|
Complete
|
2015-08-25
|
Reaffirmed
|
M53-A
|
|
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection
|
InVitro Diagnostics
|
2012-03-16
|
7-227
|
Complete
|
2011-06-30
|
Replaced
|
M56-A
|
|
Principles and Procedures for Detection of Anaerobes in Clinical Specimens
|
InVitro Diagnostics
|
2015-08-14
|
7-257
|
Complete
|
2014-07-30
|
Active
|
M58-Ed1
|
|
Methods for the Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry
|
InVitro Diagnostics
|
2017-08-21
|
7-273
|
Complete
|
2017-04-26
|
Active
|
M62- Ed1
|
M24-S
|
Performance Standards for Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes
|
InVitro Diagnostics
|
2021-06-07
|
7-292
|
Partial
|
2018-11-28
|
Replaced
|
M100-Ed33
|
M100-Ed-32
|
Performance Standards for Antimicrobial Susceptibility Testing
|
InVitro Diagnostics
|
2023-05-29
|
7-317
|
Partial
|
2023-03-03
|
Replaced
|
MM01-A3
|
MM01-A2
|
Molecular Methods for Clinical Genetics and Oncology Testing
|
InVitro Diagnostics
|
2013-01-15
|
7-237
|
Complete
|
2012-05-18
|
Replaced
|
MM03-Ed3
|
MM03-A2
|
Molecular Diagnostic Methods for Infectious Diseases
|
InVitro Diagnostics
|
2016-04-04
|
7-260
|
Complete
|
2015-02-27
|
Archived
|
MM05-A2
|
MM05-A
|
Nucleic Acid Amplification Assays for Molecular Hematopathology
|
InVitro Diagnostics
|
2019-01-14
|
7-232
|
Complete
|
2012-03-30
|
Archived
|
MM06-A2
|
MM06-A
|
Quantitative Molecular Methods for Infectious Diseases
|
InVitro Diagnostics
|
2013-01-15
|
7-238
|
Complete
|
2010-11-30
|
Reaffirmed
|
MM09-A2
|
MM09-A
|
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine
|
InVitro Diagnostics
|
2015-08-14
|
7-255
|
Partial
|
2014-02-28
|
Replaced
|
MM13-Ed2
|
MM13-A
|
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods
|
InVitro Diagnostics
|
2020-12-21
|
7-300
|
Complete
|
2020-08-25
|
Active
|
MM17-Ed2
|
|
Verification and Validation of Multiplex Nucleic Acid Assays
|
InVitro Diagnostics
|
2019-07-15
|
7-289
|
Partial
|
2018-05-31
|
Reaffirmed
|
MM18-A
|
|
Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing
|
InVitro Diagnostics
|
2009-03-18
|
7-192
|
Complete
|
2008-04-01
|
Replaced
|
MM21-Ed1
|
|
Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
|
InVitro Diagnostics
|
2016-06-27
|
7-264
|
Partial
|
2015-08-28
|
Reaffirmed
|
MM24-Ed1
|
|
Molecular Methods for Genotyping and Strain Typing of Infectious Organisms
|
InVitro Diagnostics
|
2024-05-29
|
7-321
|
Partial
|
2021-09-30
|
Active
|
MM23-Ed1
|
|
Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms)
|
InVitro Diagnostics
|
2019-01-14
|
7-269
|
Partial
|
2015-04-28
|
Active
|
NBS01-Ed7
|
|
Blood Collection on Filter Paper for Newborn Screening Programs
|
InVitro Diagnostics
|
2023-05-29
|
7-316
|
Complete
|
2021-04-16
|
Active
|
POCT01-A2
|
|
Point-of-Care Connectivity
|
Software/Informatics
|
2008-09-09
|
13-14
|
Complete
|
2006-07-28
|
Archived
|
POCT04-Ed3
|
|
Essential Tools for Implementation and Management of a Point-of-Care Testing Program
|
InVitro Diagnostics
|
2018-09-17
|
7-283
|
Complete
|
2016-06-30
|
Reaffirmed
|
POCT05-Ed2
|
POCT05-A
|
Performance Metrics for Continuous Interstitial Glucose Monitoring
|
InVitro Diagnostics
|
2021-06-07
|
7-307
|
Complete
|
2020-11-09
|
Active
|
POCT14-Ed2
|
POCT14-A
|
Point-of-Care Coagulation Testing and Anticoagulation Monitoring
|
InVitro Diagnostics
|
2020-12-21
|
7-299
|
Complete
|
2020-07-27
|
Active
|
QMS01-Ed5
|
QMS01-A4
|
A Quality Management System Model for Laboratory Services
|
InVitro Diagnostics
|
2019-12-23
|
7-293
|
Complete
|
2019-06-19
|
Active
|
QMS06-A3
|
GP22-A3
|
Quality Management System: Continual Improvement
|
InVitro Diagnostics
|
2014-01-30
|
7-223
|
Complete
|
2011-06-30
|
Reaffirmed
|
QMS24-Ed3
|
GP27-A2 and GP29-A2
|
Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality
|
InVitro Diagnostics
|
2019-01-14
|
7-139
|
Complete
|
2016-09-29
|
Reaffirmed
|