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 K243202. Device: MTS Ceftobiprole 0.002-32 µg/mL. Applicant as listed: Liofilchem s.r.l.. Decision date: 2025-01-30.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242135. Device: Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream. Applicant as listed: Nanjing Synthgene Medical Technology Co., Ltd.. Decision date: 2025-01-31.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240402. Device: Cito CBC System. Applicant as listed: Cytochip, Inc.. Decision date: 2025-02-03.
Source: api.fda.gov · Retrieved 2026-10-24
FDA 510(k) index record K242428. Device: Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus. Applicant as listed: Guangzhou Decheng Biotechnology Co., Ltd.. Decision date: 2025-02-06.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241453. Device: Elecsys sFlt-1 and Elecsys PlGF. Applicant as listed: Roche Diagnostics. Decision date: 2025-02-07.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243996. Device: AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup. Applicant as listed: Assure Tech., LLC. Decision date: 2025-02-07.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K244042. Device: Calcium2. Applicant as listed: Abbott Ireland. Decision date: 2025-02-10.
Source: api.fda.gov · Retrieved 2026-10-24
FDA 510(k) index record K242905. Device: The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2025-02-10.
Source: api.fda.gov · Retrieved 2026-10-24
FDA 510(k) index record K243201. Device: The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL. Applicant as listed: Thermo Fisher Scientific. Decision date: 2025-02-10.
Source: api.fda.gov · Retrieved 2026-10-24
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243518. Device: BinaxNOW COVID-19 Antigen Self Test. Applicant as listed: Abbott Diagnostics Scarborough, Inc.. Decision date: 2025-02-11.
Source: api.fda.gov · Retrieved 2026-10-24
FDA 510(k) K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240867. Device: cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2025-02-11.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K243575. Device: ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls. Applicant as listed: Biokit, S.A.. Decision date: 2025-02-12.
Source: api.fda.gov · Retrieved 2026-10-24
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.