Published Technical Documents
Standards, guidance and application literature from the bodies and manufacturers that publish it. Every entry links to the document page itself and quotes the sentence that says what it covers.
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Clinical and Laboratory Standards Institute (CLSI)
CLSI H59 catalogue record. Consult the publisher for the complete standard, edition and applicable requirements.
Source: clsi.org · Retrieved 2026-10-19
Clinical and Laboratory Standards Institute (CLSI)
CLSI EP10 catalogue record. Consult the publisher for the complete standard, edition and applicable requirements.
Source: clsi.org · Retrieved 2026-10-19
M07 | Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
OtherClinical and Laboratory Standards Institute (CLSI)
CLSI M07 catalogue record. Consult the publisher for the complete standard, edition and applicable requirements.
Source: clsi.org · Retrieved 2026-10-19
Clinical and Laboratory Standards Institute (CLSI)
CLSI EP06 catalogue record. Consult the publisher for the complete standard, edition and applicable requirements.
Source: clsi.org · Retrieved 2026-10-19
Clinical and Laboratory Standards Institute (CLSI)
CLSI EP09 catalogue record. Consult the publisher for the complete standard, edition and applicable requirements.
Source: clsi.org · Retrieved 2026-10-19
U.S. Food and Drug Administration
FDA source page describing its voluntary pilot program for selected oncology drugs used with in vitro diagnostic tests; participation and current status must be checked with FDA.
Source: fda.gov · Retrieved 2026-10-19
Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
Technical guidanceU.S. Food and Drug Administration
FDA guidance on development and labeling considerations for companion diagnostics intended to support a group of oncology therapeutic products.
Source: fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration
FDA special controls source document covering RNA specimen collection, stabilization and purification systems for molecular diagnostic RT-PCR.
Source: fda.gov · Retrieved 2026-10-19
Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
Technical guidanceU.S. Food and Drug Administration
FDA question-and-answer guidance about commercially distributed analyte specific reagents. Consult the original document and current FDA notices for applicable requirements.
Source: fda.gov · Retrieved 2026-10-19
In Vitro Companion Diagnostic Devices
Technical guidanceU.S. Food and Drug Administration
FDA guidance page for developers of therapeutic products and corresponding in vitro companion diagnostic devices.
Source: fda.gov · Retrieved 2026-10-19
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
Technical guidanceU.S. Food and Drug Administration
FDA source document on reporting diagnostic test study results, including the choice of comparison standard and measures of test performance.
Source: fda.gov · Retrieved 2026-10-19
Roche Diagnostics
Why structured testing algorithms matter for diagnosing infectious diseases, and how they are built.
Source: diagnostics.roche.com · Retrieved 2026-10-30
Key takeaways
Every item here is a technical document its publisher made public: a standards-body scope page, a regulator guidance document, or a manufacturer application note or journal article. The entry links to that page and quotes the sentence describing what the document covers. It is not a record of work IVDmap has done.
Target audienceImplementation teams, labs, procurement managers
Review and references
Compiled from public manufacturer materials and regulatory sources. Not independently verified and not reviewed by a named clinician.
2026-10-01
2026-10-09
professional use
Every document below is published by the body named on it, and this page links to that page. Nothing here is a record of work IVDmap has done.