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 K230238. Device: BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx. Applicant as listed: Shenzhen Bioeasy Biotechnology Co., Ltd.. Decision date: 2023-03-31.
Source: api.fda.gov · Retrieved 2026-10-28
FDA 510(k) K221802 — iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221802. Device: iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL). Applicant as listed: Mawi Dna Technologies. Decision date: 2023-04-03.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230035. Device: BioSci Disposable Virus Sampling Tubes. Applicant as listed: Shenzhen Dakewe Bio-Engineering Co., Ltd.. Decision date: 2023-04-05.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221493. Device: MicroScan Prompt Inoculation System-D. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-04-05.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220456. Device: Elecsys FT4 IV. Applicant as listed: Roche Diagnostics. Decision date: 2023-04-07.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230719. Device: BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini. Applicant as listed: Biofire Diagnostics, LLC. Decision date: 2023-04-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220763. Device: ALPCO Calprotectin Immunoturbidimetric Assay. Applicant as listed: ALPCO. Decision date: 2023-04-13.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193514. Device: AUTION MAX AX-4060 Urinalysis System. Applicant as listed: Arkray, Inc.. Decision date: 2023-04-13.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230868. Device: SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control. Applicant as listed: Maine Molecular Quality Controls, Inc.. Decision date: 2023-04-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222829. Device: Curian® Shiga Toxin. Applicant as listed: Meridian Bioscience, Inc.. Decision date: 2023-04-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211748. Device: Selux AST System; Model AST Gen 1.0. Applicant as listed: Selux Diagnostics, Inc.. Decision date: 2023-04-19.
Source: api.fda.gov · Retrieved 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222996. Device: Access PCT. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-04-26.
Source: api.fda.gov · Retrieved 2026-10-28
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.