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 K233126. Device: aetherSlide. Applicant as listed: Aetherai Co., Ltd.. Decision date: 2024-05-30.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232715. Device: Distinct® Digital Pregnancy Test. Applicant as listed: ACON Laboratories, Inc.. Decision date: 2024-05-31.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233842. Device: iHealth COVID-19 Antigen Rapid Test. Applicant as listed: Ihealth Labs, Inc.. Decision date: 2024-05-31.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220062. Device: QIAstat-Dx Gastrointestinal Panel 2. Applicant as listed: QIAGEN GmbH. Decision date: 2024-05-31.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231151. Device: Kenota 1 Total IgE; Kenota 1 (instrument). Applicant as listed: Kenota, Inc.. Decision date: 2024-05-31.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240627. Device: LIAISON PLEX Yeast Blood Culture Assay. Applicant as listed: Luminex Corporation. Decision date: 2024-06-04.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241304. Device: WaveSense Jazz Blood Glucose Monitoring System. Applicant as listed: Agamatrix. Decision date: 2024-06-06.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233861. Device: Libre Rio Continuous Glucose Monitoring System. Applicant as listed: Abbott Diabetes Care. Decision date: 2024-06-07.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221547. Device: InActiv Blue. Applicant as listed: Fertipro NV. Decision date: 2024-06-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240124. Device: BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2024-06-14.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232879. Device: Roche Digital Pathology Dx (VENTANA DP 200). Applicant as listed: Ventana Medical Systems, Inc.. Decision date: 2024-06-14.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) K241428 — AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241428. Device: AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2024-06-17.
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.