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 K233605. Device: ADVIA Centaur EBV-EBNA IgG. Applicant as listed: Biokit, S.A.. Decision date: 2024-08-07.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233606. Device: ADVIA Centaur EBV-VCA IgM. Applicant as listed: Biokit, S.A.. Decision date: 2024-08-07.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232404. Device: CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES. Applicant as listed: Medicon Hellas S.A. Decision date: 2024-08-09.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240469. Device: Access TPO Antibody. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-08-09.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233367. Device: iDart Lyme IgG ImmunoBlot Kit. Applicant as listed: Id-Fish Technology, Inc.. Decision date: 2024-08-12.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241978. Device: Shinetell Digital Pregnancy Test. Applicant as listed: Hangzhou AllTest Biotech Co., Ltd.. Decision date: 2024-08-13.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242077. Device: PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup. Applicant as listed: Aicheck Biotech, Inc.. Decision date: 2024-08-14.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K241969. Device: Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel. Applicant as listed: Qingdao Hightop Biotech Co., Ltd.. Decision date: 2024-08-14.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K242127. Device: ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS). Applicant as listed: Instrumentation Laboratory (IL) Co.. Decision date: 2024-08-16.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222126. Device: VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2024-08-16.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240235. Device: OmniTrans Transport System. Applicant as listed: Shenzhen Dakewe Bio-Engineering Co., Ltd.. Decision date: 2024-08-19.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233358. Device: SCoV-2 Ag Detect Rapid Test. Applicant as listed: InBios International, Inc.. Decision date: 2024-08-23.
Source: api.fda.gov · Retrieved 2026-10-19
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.