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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U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260233. Device: Elecsys EBV IgM. Applicant as listed: Roche Diagnostics. Decision date: 2026-10-02.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260468. Device: H100Plus Hemoglobin Testing System. Applicant as listed: Shenzhen Lifotronic Technology Co., Ltd.. Decision date: 2026-10-02.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260689. Device: CVS Advanced PLUS Blood Glucose Monitoring System. Applicant as listed: I-Sens, Inc.. Decision date: 2026-10-02.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K263120. Device: Xpert Xpress CoV-2/Flu plus. Applicant as listed: Cepheid®. Decision date: 2026-10-02.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260221. Device: Elecsys EBV EBNA IgG. Applicant as listed: Roche Diagnostics. Decision date: 2026-10-02.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260232. Device: Elecsys EBV VCA IgG. Applicant as listed: Roche Diagnostics. Decision date: 2026-10-02.
Source: api.fda.gov · Retrieved 2026-10-21
Clinical and Laboratory Standards Institute (CLSI)
CLSI MM29 catalogue record. Consult the publisher for the complete standard, edition and applicable requirements.
Source: clsi.org · Retrieved 2026-10-21
Clinical and Laboratory Standards Institute (CLSI)
CLSI MM06 catalogue record. Consult the publisher for the complete standard, edition and applicable requirements.
Source: clsi.org · Retrieved 2026-10-21
Clinical and Laboratory Standards Institute (CLSI)
CLSI M27M44S catalogue record. Consult the publisher for the complete standard, edition and applicable requirements.
Source: clsi.org · Retrieved 2026-10-21
Clinical and Laboratory Standards Institute (CLSI)
CLSI M38M51S catalogue record. Consult the publisher for the complete standard, edition and applicable requirements.
Source: clsi.org · Retrieved 2026-10-21
Clinical and Laboratory Standards Institute (CLSI)
CLSI C65 catalogue record. Consult the publisher for the complete standard, edition and applicable requirements.
Source: clsi.org · Retrieved 2026-10-21
Clinical and Laboratory Standards Institute (CLSI)
CLSI M100 catalogue record. Consult the publisher for the complete standard, edition and applicable requirements.
Source: clsi.org · Retrieved 2026-10-20
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.