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 K232643. Device: Cue COVID-19 Molecular Test. Applicant as listed: Cue Health, Inc.. Decision date: 2023-11-28.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231476. Device: TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System. Applicant as listed: Sinocare, Inc.. Decision date: 2023-12-01.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232308. Device: Monarch Blood Collection Set. Applicant as listed: The Monarch Company. Decision date: 2023-12-04.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223783. Device: cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2023-12-04.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232434. Device: BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit. Applicant as listed: Bd. Decision date: 2023-12-05.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231465. Device: Q-Pad Test System. Applicant as listed: Qurasense. Decision date: 2023-12-06.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232761. Device: ProNephro AKI (NGAL). Applicant as listed: Bioporto Diagnostic, Inc.. Decision date: 2023-12-07.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223690. Device: iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C). Applicant as listed: Shenzhen Yhlo Biotech Co., Ltd.. Decision date: 2023-12-11.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230852. Device: HemosIL Chromogenic Factor IX. Applicant as listed: Instrumentation Laboratory Company. Decision date: 2023-12-13.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233019. Device: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2023-12-13.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233663. Device: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM). Applicant as listed: Siemens Healthcare Diagnostics Products GmbH. Decision date: 2023-12-13.
Source: api.fda.gov · Retrieved 2026-10-27
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232659. Device: Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup. Applicant as listed: Guangzhou Decheng Biotechnology Co., Ltd.. Decision date: 2023-12-13.
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.