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 K252378. Device: BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube. Applicant as listed: Becton, Dickinson and Company. Decision date: 2026-04-10.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252207. Device: ABL90 FLEX PLUS System, safeCLINITUBES. Applicant as listed: Radiometer Medicals Aps. Decision date: 2026-04-10.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260095. Device: Heal-Check Rapid COVID-19 Antigen Self-Test. Applicant as listed: Healgen Scientific,, LLC. Decision date: 2026-04-13.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252280. Device: Elecsys Anti-SARS-CoV-2 S. Applicant as listed: Roche Diagnostics. Decision date: 2026-04-13.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252728. Device: IDS-iSYS Total Testosterone. Applicant as listed: Immunodiagnostic Systems Limited. Decision date: 2026-04-15.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K253573. Device: ASTar BC G- Kit. Applicant as listed: Q-Linea AB. Decision date: 2026-04-15.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260282. Device: VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance. Applicant as listed: bioMerieux, Inc.. Decision date: 2026-04-15.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260128. Device: BD Preset and BD A-Line Arterial Blood Collection Syringes. Applicant as listed: Becton, Dickinson and Company. Decision date: 2026-04-15.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260696. Device: MTS Gepotidacin 0.016-256 µg/mL. Applicant as listed: Liofilchem s.r.l.. Decision date: 2026-04-17.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260447. Device: ETEST Gepotidacin (GEP) (0.016-256 µg/mL). Applicant as listed: bioMérieux SA. Decision date: 2026-04-21.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K252431. Device: Elecsys Calcitonin. Applicant as listed: Roche Diagnostics GmbH. Decision date: 2026-04-24.
Source: api.fda.gov · Retrieved 2026-10-22
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260429. Device: Control-IQ+ technology. Applicant as listed: Tandem Diabetes Care, Inc.. Decision date: 2026-04-24.
Source: api.fda.gov · Retrieved 2026-10-22
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.