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 K230349. Device: Lyra RSV+hMPV Assay. Applicant as listed: Quidel Corporation. Decision date: 2023-03-10.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223162. Device: Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT. Applicant as listed: Healgen Scientific,, LLC. Decision date: 2023-03-17.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K221119. Device: RCRP Flex reagent cartridge. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2023-03-17.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220963. Device: Simplexa COVID-19 & Flu A/B Direct. Applicant as listed: Diasorin Molecular, LLC. Decision date: 2023-03-17.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223844. Device: Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae). Applicant as listed: Thermo Fisher Scientific. Decision date: 2023-03-21.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220026. Device: Genomadix Cube CYP2C19 System. Applicant as listed: Genomadix, Inc.. Decision date: 2023-03-21.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K213362. Device: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel. Applicant as listed: Biofire Defense, LLC. Decision date: 2023-03-22.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222559. Device: BD BACTEC Myco/F Lytic Culture Vials. Applicant as listed: Becton, Dickinson and Company. Decision date: 2023-03-24.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222591. Device: BD BACTEC Plus Aerobic/F Culture Vials. Applicant as listed: Becton, Dickinson and Company. Decision date: 2023-03-24.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K223323. Device: Blood Collection Needle (with/without Needle Holder). Applicant as listed: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Decision date: 2023-03-24.
Fuente: api.fda.gov · Consultado el 2026-10-28
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K220212. Device: BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder. Applicant as listed: Becton, Dickinson and Company. Decision date: 2023-03-24.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230161. Device: ONLINE TDM Phenytoin - Free Phenytoin application. Applicant as listed: Roche Diagnostics. Decision date: 2023-03-30.
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.