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 K220803. Device: VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin. Applicant as listed: bioMerieux, Inc.. Decision date: 2023-01-27.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223016. Device: BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit. Applicant as listed: Bd. Decision date: 2023-01-27.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K203833. Device: Tacrolimus Assay Kit. Applicant as listed: Shanghai Genext Medical Technology Co., Ltd.. Decision date: 2023-01-27.
Fuente: api.fda.gov · Consultado el 2026-10-29
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223090. Device: GEM Premier ChemSTAT. Applicant as listed: Instrumentation Laboratory CO. Decision date: 2023-01-27.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221253. Device: SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control. Applicant as listed: Maine Molecular Quality Controls, Inc.. Decision date: 2023-02-03.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223679. Device: Access AMH. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-02-03.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213954. Device: BIOFIRE SPOTFIRE Respiratory (R) Panel. Applicant as listed: Biofire Diagnostics. Decision date: 2023-02-03.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223038. Device: Access Cortisol. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-02-08.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223478. Device: VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin. Applicant as listed: bioMerieux, Inc.. Decision date: 2023-02-16.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223497. Device: Spectrum Saliva Collection Device. Applicant as listed: Spectrum Solutions, LLC. Decision date: 2023-02-17.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K214068. Device: Quantia IgE. Applicant as listed: Biokit, S.A.. Decision date: 2023-02-21.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223537. Device: FreeStyle Libre 2 System, FreeStyle Libre 3 System. Applicant as listed: Abbott Diabetes Care, Inc.. Decision date: 2023-02-21.
Fuente: api.fda.gov · Consultado el 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.