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 K190397. Device: Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA. Applicant as listed: Immunalysis Corporation. Decision date: 2019-11-15.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192299. Device: LZI Cotinine II Enzyme Immunoassay. Applicant as listed: Lin-Zhi International, Inc.. Decision date: 2019-11-21.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192843. Device: INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream. Applicant as listed: Innovita (Tangshan) Biological Technology Co., Ltd.. Decision date: 2019-11-22.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192777. Device: ADVIA Centaur CA 15-3 assay. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2019-11-22.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193041. Device: Hemochron Signature Elite. Applicant as listed: Accriva Diagnostics, Inc.. Decision date: 2019-11-22.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192788. Device: ADVIA Centaur Cortisol (COR). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2019-11-25.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192271. Device: Access PCT, Access PCT Calibrators. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2019-11-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192376. Device: Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack. Applicant as listed: Diasorin Molecular, LLC. Decision date: 2019-11-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K192738. Device: ETEST Delafloxacin (DFX) (0.002-32 µg/mL). Applicant as listed: Biomerieux S.A.. Decision date: 2019-11-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K190710. Device: EliA SymphonyS Immunoassay. Applicant as listed: Phadia AB. Decision date: 2019-11-29.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K190968. Device: CEDIA Benzodiazepine Assay. Applicant as listed: Microgenics Corporation. Decision date: 2019-12-09.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K193167. Device: NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software. Applicant as listed: Luminex Molecular Diagnostics, Inc.. Decision date: 2019-12-11.
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.