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.
Filter documents
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260613. Device: AMI Plasma Cartridge, AMI. Applicant as listed: Sequitur Health Corp.. Decision date: 2026-09-01.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K254264. Device: Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA. Applicant as listed: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho). Decision date: 2026-09-04.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K254262. Device: Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA. Applicant as listed: Ortho Clinical Diagnostics Inc. (QuidelOrtho). Decision date: 2026-09-04.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260331. Device: IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13). Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd.. Decision date: 2026-09-04.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260062. Device: MODI System. Applicant as listed: DreaMed Diabetes, Ltd.. Decision date: 2026-09-08.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261409. Device: BioTeke® Multi-Drug Urine Test Cup. Applicant as listed: Bioteke Corporation (Wuxi) Co., Ltd.. Decision date: 2026-09-10.
Source: api.fda.gov · Retrieved 2026-10-20
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262763. Device: iLet Dosing Decision Software. Applicant as listed: Beta Bionics, Inc.. Decision date: 2026-09-11.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261837. Device: FINDER Flu A&B/SARS-CoV-2 Test. Applicant as listed: Baebies, Inc.. Decision date: 2026-09-11.
Source: api.fda.gov · Retrieved 2026-10-21
FDA 510(k) K262163 — BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth
OtherU.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262163. Device: BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth. Applicant as listed: Becton Dickinson and Company. Decision date: 2026-09-14.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K260781. Device: Yumizen H550. Applicant as listed: HORIBA ABX SAS. Decision date: 2026-09-14.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K261896. Device: iOS CamAPS FX. Applicant as listed: CamDiab. Decision date: 2026-09-16.
Source: api.fda.gov · Retrieved 2026-10-21
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K262599. Device: Biolinq Shine Autonomous Time-in-Range Microsensor. Applicant as listed: Biolinq Incorporated. Decision date: 2026-09-18.
Source: api.fda.gov · Retrieved 2026-10-21
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.