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 K241652. Device: DASH® SARS-CoV-2 & Flu A/B Test. Applicant as listed: Nuclein, LLC. Decision date: 2024-12-20.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233119. Device: 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T. Applicant as listed: Shenzhen Beacon Display Technology Co., Ltd.. Decision date: 2024-12-28.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240984. Device: i-STAT hs-TnI cartridge with the i-STAT 1 System. Applicant as listed: Abbott Point of Care, Inc.. Decision date: 2025-01-03.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241456. Device: GlutenID Celiac Genetic Health Risk Test. Applicant as listed: Targeted Genomics, LLC. Decision date: 2025-01-07.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243813. Device: QIAstat-Dx GI Panel 2 Mini B&V. Applicant as listed: QIAGEN GmbH. Decision date: 2025-01-08.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241806. Device: Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel. Applicant as listed: Life Technologies Corporation. Decision date: 2025-01-08.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241273. Device: FullFocus. Applicant as listed: Paige.Ai, Inc.. Decision date: 2025-01-09.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241676. Device: TriVerity. Applicant as listed: Inflammatix, Inc.. Decision date: 2025-01-10.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242767. Device: Safecare Urinary Tract Infection Test. Applicant as listed: Safecare Biotech (Hangzhou) Co., Ltd.. Decision date: 2025-01-10.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242877. Device: BioCode Gastrointestinal Pathogen Panel (GPP). Applicant as listed: Applied BioCode, Inc.. Decision date: 2025-01-10.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243262. Device: QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test. Applicant as listed: Osang, LLC. Decision date: 2025-01-13.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243573. Device: FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream. Applicant as listed: Assure Tech., LLC. Decision date: 2025-01-15.
Source: api.fda.gov · Retrieved 2026-10-24
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.