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 K233100. Device: QIAstat-Dx® Respiratory Panel Plus. Applicant as listed: QIAGEN GmbH. Decision date: 2024-05-10.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240949. Device: Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen® Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen® Accurate Fentanyl Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine). Applicant as listed: Healgen Scientific,, LLC. Decision date: 2024-05-13.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) index record K240445. Device: The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.. Applicant as listed: Thermo Fisher Scientific. Decision date: 2024-05-16.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241110. Device: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4). Applicant as listed: Centers for Disease Control and Prevention. Decision date: 2024-05-21.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232946. Device: Yumizen H2500. Applicant as listed: HORIBA ABX SAS. Decision date: 2024-05-21.
Source: api.fda.gov · Retrieved 2026-10-26
FDA 510(k) K241100 — Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241100. Device: Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard. Applicant as listed: Co-Innovation Biotech Co., Ltd.. Decision date: 2024-05-22.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232603. Device: CamAPS FX. Applicant as listed: Camdiab , Ltd.. Decision date: 2024-05-23.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233655. Device: Lingo Glucose System. Applicant as listed: Abbott. Decision date: 2024-05-29.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232672. Device: EasyScreen Gastrointestinal Parasite Detection Kit. Applicant as listed: Genetic Signatures Limited. Decision date: 2024-05-29.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232741. Device: SmartAdjust(TM) technology. Applicant as listed: Insulet Corporation. Decision date: 2024-05-29.
Source: api.fda.gov · Retrieved 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241194. Device: BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini. Applicant as listed: Biofire Diagnostics, LLC. 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 K241289. Device: SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control. Applicant as listed: Maine Molecular Quality Controls, Inc.. Decision date: 2024-05-30.
Source: api.fda.gov · Retrieved 2026-10-26
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.