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 K243463. Device: BIOFIRE FILMARRAY Tropical Fever Panel. Applicant as listed: Biofire Diagnostics, LLC (Biomerieux). Decision date: 2024-12-05.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242653. Device: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2024-12-05.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241580. Device: Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086). Applicant as listed: Abbott Molecular. Decision date: 2024-12-06.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243498. Device: Alinity c Benzodiazepines Reagent Kit. Applicant as listed: Microgenics Corporation. Decision date: 2024-12-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223093. Device: Aptiva APS IgG Reagent; Aptiva APS IgM Reagent. Applicant as listed: Inova Diagnostics, Inc.. Decision date: 2024-12-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243365. Device: Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup. Applicant as listed: Healgen Scientific,, LLC. Decision date: 2024-12-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242783. Device: Roche Digital Pathology Dx. Applicant as listed: Ventana Medical Systems, Inc.. Decision date: 2024-12-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243625. Device: Xpert MRSA/SA SSTI. Applicant as listed: Cepheid®. Decision date: 2024-12-18.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243725. Device: BD Vaginal Panel. Applicant as listed: Becton, Dickinson and Company. Decision date: 2024-12-19.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243169. Device: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2024-12-19.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243759. Device: BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)). Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2024-12-20.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241394. Device: iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip. Applicant as listed: Andon Health Co, Ltd.. Decision date: 2024-12-20.
Source: api.fda.gov · Retrieved 2026-10-19
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.