Buscar en IVDmap

Busque productos, empresas, pruebas y guías: pase de la consulta a la solicitud de cotización en un solo lugar.

Artículo

Impact of repeated population-wide active TB screening and decentralized molecular diagnostics on TB burden in Lakshadweep, India.

Research record from Indian J Tuberc, 2026-08-18. PMID 42790960.

Artículo

Implementation of an in-house real-time PCR assay as a diagnostic tool for Invasive Aspergillosis in haematology patients: a prospective diagnostic accuracy study.

Research record from Indian J Med Microbiol, 2026-07-19. PMID 42472584.

Glossary Term

In Vitro Diagnostic Device

A reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information to aid towards a diagnosis.

Regulatory Definitions

Glossary Term

In Vitro Diagnostic Regulation (IVDR)

EU Regulation 2017/746 governing in vitro diagnostics, which replaced the IVDD with stricter evidence, post-market surveillance, and reclassification rules. Products legacy-listed under the IVDD may still carry transitional timelines, so registration status should be verified per product and per market.

Regulatory Definitions

Artículo