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 K242095. Device: Access Toxo IgM II. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-10-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240468. Device: Alkaline Phosphatase. Applicant as listed: Abbott Laboratories Diagnostics Division. Decision date: 2024-10-16.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240865. Device: IDS-iSYS Free Testosterone. Applicant as listed: Immunodiagnostic Systems Limited. Decision date: 2024-10-23.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242353. Device: QIAstat-Dx Respiratory Panel Mini. Applicant as listed: QIAGEN GmbH. Decision date: 2024-10-25.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243070. Device: Xpert® SA Nasal Complete. Applicant as listed: Cepheid®. Decision date: 2024-10-25.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240303. Device: MetaLite DX Digital Pathology Software. Applicant as listed: Jellox Biotech, Inc.. Decision date: 2024-10-28.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242256. Device: QIAstat-Dx Meningitis/Encephalitis (ME) Panel. Applicant as listed: QIAGEN GmbH. Decision date: 2024-10-29.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240670. Device: DRI Ecstasy Plus Assay. Applicant as listed: Microgenics Corporation. Decision date: 2024-10-30.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240455. Device: BD Vacutainer® Citrate Blood Collection Tubes. Applicant as listed: Becton, Dickinson and Company. Decision date: 2024-10-31.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242320. Device: BD Vacutainer® One Use Holder. Applicant as listed: Becton, Dickinson and Company. Decision date: 2024-11-01.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240637. Device: RIGHTEST Blood Glucose Monitoring System Max Tel. Applicant as listed: Bionime Corporation. Decision date: 2024-11-04.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243222. Device: BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus). Applicant as listed: Biofire Diagnostics, LLC (Biomerieux). Decision date: 2024-11-06.
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.