Quality Certificates
We strive to foster and maintain a sustainable quality culture within the Company, to continuously develop our employees’ skills and improve our processes to meet and anticipate customer expectations.
⚠️ Please note that if you're looking for Certificates of Analysis (CoA) and Certificates of Quality (CoQ), you can find them in our Resource Center using your customer credentials.
Manufacturing
Find here our Manufacturing Quality Certificates and click on the link to consult the documents.
Australia | |
| Brazil | |
| Canada - LUMED | |
| China - Shanghai | ISO 13485 |
| China - Suzhou | ISO 13485 |
| France | IVDR bioMerieux SA certificate - 38813-8 IVDR bioMerieux SA certificate - 38814-4 IVDR bioMerieux SA certificate - 38815-10 IVDR bioMerieux SA certificate - 38817-17 IVDR bioMerieux SA certificate - 38820-4 IVDR bioMerieux SA certificate - 38906-0 IVDR bioMerieux SA certificate - 39239-14 IVDR bioMerieux SA certificate - 40536-0 Address change notification for Combourg site (17MAR2023) |
| Italy | |
| India - Hyderabad | ISO 13485 |
| Spain | |
| USA |
IVDR bioMérieux Inc certificate - 38919-6 IVDR bioMérieux Inc certificate - 39273-1 IVDR bioMérieux Inc certificate - 39290-3 IVDR bioMérieux Inc certificate - 39291-10 |
| USA - Lombard | ISO 9001 |
| USA - BioFire Diagnostics |
EU 2024-1860/1144428 Confirmation Letter IVDR BioFire Diagnostics certificate - 735494 |
| USA - Specific Diagnostics | ISO 13485 |
Subsidiary/Country
Find here Quality Certificates by subsidiary/country and click on the link to consult the document.
| Argentina | |
| Australia | |
| Austria | |
| Benelux | |
| Brazil | |
| Canada | |
Central European Cluster | ISO 9001 |
| Chile | |
| China | |
| Colombia | |
| Czech Republic | |
Egypt | ISO 9001 |
| Europe SSC | |
| France | |
| Germany | |
| Greece | |
| Hungary | |
| Iberia | ISO 9001 |
| India | |
| Italy | |
| Japan | |
| Korea | |
| Latin America SSC | |
| Mexico | |
| Nordics | |
| Philippines | ISO 9001 |
| Poland | |
| Russia | |
| Singapore | |
| South Africa | |
| Switzerland | |
| Thailand | |
| Turkey | |
| UK | |
| USA |
Products
Find here our Products Quality Certificates which concern the legal manufacturer and click on the link to consult the document.
| ETEST® | |
| VITEK® 2 | |
| VITEK® MS | |
| VIDAS® | |
| BACT/ALERT® |
For other products, please click here.