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 K203035. Device: Eonis SCID-SMA kit. Applicant as listed: Perkinelmer, Inc.. Decision date: 2022-11-09.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222667. Device: Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2022-11-10.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221225. Device: Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2022-11-10.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223185. Device: BreathID® Smart System. Applicant as listed: Meridian Bioscience Israel , Ltd.. Decision date: 2022-11-10.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220739. Device: Disposable Urine Collection Tube. Applicant as listed: Zhejiang Gongdong Medical Technology Co., Ltd.. Decision date: 2022-11-17.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223293. Device: CONTOUR® NEXT GEN Blood Glucose Monitoring System. Applicant as listed: Ascensia Diabetes Care U.S., Inc.. Decision date: 2022-11-18.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222299. Device: Steripath Micro Blood Collection System. Applicant as listed: Magnolia Medical Technologies. Decision date: 2022-11-30.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222305. Device: MissLan Digital Pregnancy Rapid Test. Applicant as listed: Guangzhou Decheng Biotechnology Co., Ltd.. Decision date: 2022-11-30.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221842. Device: Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF. Applicant as listed: Roche Diagnostics. Decision date: 2022-12-07.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223402. Device: HemosIL von Willebrand Factor Antigen. Applicant as listed: Instrumentation Laboratory CO. Decision date: 2022-12-09.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223403. Device: LIAISON Anti-HAV; LIAISON XS. Applicant as listed: DiaSorin, Inc.. Decision date: 2022-12-09.
Source: api.fda.gov · Retrieved 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221355. Device: VITROS Immuodiagnostic Products CA 125 II Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2022-12-12.
Source: api.fda.gov · Retrieved 2026-10-29
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.