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 K222613. Device: ARX Liquid Amies Collection & Transport System. Applicant as listed: Arx Sciences, Inc.. Decision date: 2024-03-27.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K234143. Device: i-STAT TBI Cartridge with the i-STAT Alinity System. Applicant as listed: Abbott Point of Care. Decision date: 2024-03-27.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240295. Device: InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine). Applicant as listed: Instanosis, Inc.. Decision date: 2024-03-28.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232018. Device: Citrated: K, KH, RTH, FFH. Applicant as listed: Haemonetics Corporation. Decision date: 2024-03-29.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K211815. Device: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System. Applicant as listed: Affinity Biosensors. Decision date: 2024-04-02.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232027. Device: CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument. Applicant as listed: Sebia. Decision date: 2024-04-04.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K233050. Device: ADVIA Centaur® TSH3-Ultra II (TSH3ULII). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2024-04-04.
Fuente: api.fda.gov · Consultado el 2026-10-19
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K234152. Device: ACESO Early Pregnancy Test. Applicant as listed: Aceso Laboratories, Inc.. Decision date: 2024-04-05.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K212878. Device: Sample preservation solution. Applicant as listed: Zhejiang Gene Science Co., Ltd.. Decision date: 2024-04-08.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K240654. Device: SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette. Applicant as listed: Safecare Biotech (Hangzhou) Co., Ltd.. Decision date: 2024-04-10.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K202531. Device: Azer Scientific Universal Transport Medium. Applicant as listed: Azer Scientific, Inc.. Decision date: 2024-04-11.
Fuente: api.fda.gov · Consultado el 2026-10-26
U.S. Food and Drug Administration (FDA)
FDA 510(k) index record K232587. Device: MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer. Applicant as listed: Shenzhen New Industries Biomedical Engineering Co., Ltd.. Decision date: 2024-04-12.
Fuente: api.fda.gov · Consultado el 2026-10-26
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.