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 K243858. Device: TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge. Applicant as listed: Haemonetics Corporation. Decision date: 2025-01-15.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242109. Device: Xpert® Xpress CoV-2 plus (XPRS-COV2-10). Applicant as listed: Cepheid®. Decision date: 2025-01-15.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243256. Device: WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest. Applicant as listed: Wondfo USA Co, Ltd.. Decision date: 2025-01-16.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243885. Device: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid. Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2025-01-16.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241176. Device: Alere NT-proBNP for Alinity i Reagent Kit. Applicant as listed: Axis-Shield Diagnostics, Ltd.. Decision date: 2025-01-16.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243935. Device: Aptima CMV Quant Assay. Applicant as listed: Hologic, Inc.. Decision date: 2025-01-17.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241220. Device: Tina-quant Lipoprotein(a) Gen.2 Molarity. Applicant as listed: Roche Diagnostics Operations. Decision date: 2025-01-24.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241232. Device: Galen Second Read. Applicant as listed: Ibex Medical Analytics , Ltd.. Decision date: 2025-01-24.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243374. Device: HemosIL CL HIT-IgG(PF4-H). Applicant as listed: Instrumentation Laboratory (IL) Co.. Decision date: 2025-01-28.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241915. Device: CareSuperb COVID-19 Antigen Home Test. Applicant as listed: Access Bio, Inc.. Decision date: 2025-01-29.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243060. Device: TeleRPM Gen2 Blood Glucose Monitoring System. Applicant as listed: Guangdong Transtek Medical Electronics Co., Ltd.. Decision date: 2025-01-30.
Fuente: api.fda.gov · Consultado el 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243410. Device: simpli-COLLECT STI Test. Applicant as listed: Abbott Molecular. Decision date: 2025-01-30.
Fuente: api.fda.gov · Consultado el 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.