Labtest Diagnóstica S.A.
In vitro diagnostic reagents and instruments
Leading Brazilian manufacturer of clinical chemistry and immunochemistry reagents, as well as automated analyzers. Labtest equips laboratories throughout Latin America with diagnostic solutions.
- Type
- Manufacturer
- Location
- Lagoa Santa, Brazil
- Founded
- 1971
- Website
- https://www.labtest.com.br
- Categories
- Medical & Healthcare Supplies
- Markets
- Brazil, Argentina, Colombia, Portugal
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)