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 K262109. Device: Access NT-proBNP. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2026-09-21.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K263054. Device: BIOFIRE Respiratory Panel 2.1 (RP2.1). Applicant as listed: Biofire Diagnostics. Decision date: 2026-09-22.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262299. Device: Instant-View® hCG Combo II Cassette Test. Applicant as listed: Alfa Scientific Designs, Inc.. Decision date: 2026-09-22.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262156. Device: Anti-HCV Next. Applicant as listed: Abbott Laboratories. Decision date: 2026-09-23.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260214. Device: STA® - Liquid Anti-Xa. Applicant as listed: Diagnostica Stago, Inc.. Decision date: 2026-09-24.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262168. Device: QIAstat-Dx BCID GN Plus AMR Panel. Applicant as listed: QIAGEN GmbH. Decision date: 2026-09-24.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260023. Device: TumorSight Risk. Applicant as listed: SimBioSys, Inc.. Decision date: 2026-09-25.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262215. Device: Profoject Safety Sliding Blood Collection Set. Applicant as listed: CMT Health PTE., Ltd.. Decision date: 2026-09-25.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261336. Device: Xpert Respiratory Panel. Applicant as listed: Cepheid. Decision date: 2026-09-25.
Source: api.fda.gov · Retrieved 2026-10-21
FDA 510(k) index record K263035. Device: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit). Applicant as listed: Centers for Disease Control and Prevention. Decision date: 2026-09-30.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262893. Device: Eonis SMA kit. Applicant as listed: Revvity, Inc.. Decision date: 2026-09-30.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260283. Device: VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL). Applicant as listed: bioMerieux, Inc.. Decision date: 2026-10-01.
Source: api.fda.gov · Retrieved 2026-10-21
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.