Labtest Diagnóstica S.A.
Реактивы и инструменты для диагностики in vitro
Ведущий бразильский производитель реагентов для клинической химии и иммунохимии, а также автоматических анализаторов. Labtest оснащает лаборатории по всей Латинской Америке диагностическими решениями.
- Type
- Manufacturer
- Location
- Lagoa Santa, Brazil
- Founded
- 1971
- Website
- https://www.labtest.com.br
- Categories
- Медицинские товары и расходники
- Markets
- Бразилия, Аргентина, Колумбия, Португалия
Verified facts
- domain-registered (green), checked 2026-08-24 Domain registry record
- sanctions-clear (green), checked 2026-08-24 OpenSanctions
- debarment-clear (green), checked 2026-08-24 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-24 Mail server of the company domain
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- FDA Registered FDA Establishment Registration
- Good Manufacturing Practice
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)