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 K233060. Device: Elecsys Folate III. Applicant as listed: Roche Diagnostics. Decision date: 2024-06-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233324. Device: Molecular Transport Media - MTM. Applicant as listed: Alb Luz. Decision date: 2024-06-17.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K230675. Device: VITEK REVEAL GN AST Assay and VITEK REVEAL AST System. Applicant as listed: Specific Diagnostics, LLC. Decision date: 2024-06-20.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240728. Device: CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test. Applicant as listed: CorDx, Inc.. Decision date: 2024-06-21.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240643. Device: MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream. Applicant as listed: Guangzhou Decheng Biotechnology Co., Ltd.. Decision date: 2024-06-21.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K222771. Device: Sample Preservative Fluid. Applicant as listed: Hangzhou Bioer Technology Co., Ltd.. Decision date: 2024-06-26.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240927. Device: Access Thyroglobulin. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-06-28.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240987. Device: Access sTfR. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-07-03.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240996. Device: Access Thyroglobulin Antibody II. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-07-03.
Source: api.fda.gov · Retrieved 2026-10-19
FDA 510(k) index record K240252. Device: UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2024-07-05.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233453. Device: Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit. Applicant as listed: Life Technologies Corporation. Decision date: 2024-07-10.
Source: api.fda.gov · Retrieved 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233449. Device: Avantik VTM. Applicant as listed: Hanchang Medic Co., Ltd. (Han Chang Medic). Decision date: 2024-07-15.
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.