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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FDA 510(k) index record K241741. Device: SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel. Applicant as listed: Guangzhou Wondfo Biotech Co., Ltd.. Decision date: 2024-07-16.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233979. Device: VACUETTE® QUICKSHIELD Complete (Plus). Applicant as listed: Greiner Bio-One North America, Inc.. Decision date: 2024-07-19.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K234091. Device: Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0. Applicant as listed: Genalyte, Inc.. Decision date: 2024-07-22.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233352. Device: Aptima HCV Quant Dx Assay. Applicant as listed: Hologic, Inc.. Decision date: 2024-07-24.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241165. Device: Atellica® IM High-Sensitivity Troponin I (TnIH). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2024-07-25.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K231776. Device: Cell-Free DNA BCT. Applicant as listed: Streck, Inc.. Decision date: 2024-07-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220328. Device: EasyStat 300. Applicant as listed: Medica Corporation. Decision date: 2024-07-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241800. Device: Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2024-07-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240280. Device: Nano-Check RSV Test. Applicant as listed: Nano-Ditech Corporation. Decision date: 2024-07-30.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233541. Device: ARCHITECT Active-B12 (Holotranscobalamin). Applicant as listed: Axis-Shield Diagnostics, Ltd.. Decision date: 2024-07-31.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233534. Device: Viral Transport Medium. Applicant as listed: Hardy Diagnostics. Decision date: 2024-08-02.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241919. Device: Innovita HCG Pregnancy Rapid Combo Test. Applicant as listed: Innovita (Tangshan) Biological Technology Co., Ltd.. Decision date: 2024-08-02.
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.