Human diagnostics
The following regulatory and ordering information applies to our human diagnostics portfolio.
- Quality management system
- ISO 13485:2016 — both manufacturing facilities
- Regulatory framework
- Regulation (EU) 2017/746 (IVDR); CE marking held for the majority of the portfolio, remainder in conformity assessment
- EU Authorised Representative
- OBELIS S.A., Bd. Général Wahis 53, 1030 Brussels, Belgium
- Intended user
- Professional use — trained clinical laboratory personnel
- Storage and shipping
- Kits shipped on dry ice or cold packs as stated in each IFU; store at -20 °C unless otherwise specified
- Instructions for use
- Current IFU revision supplied with each kit and available on request
- Ordering
- Quote the full REF and pack-size suffix; minimum order quantities and lead times on request
- Availability
- Product availability and regulatory status vary by country; not all products are registered in all markets
Veterinary diagnostics
Veterinary reagents are not in vitro diagnostic medical devices within the meaning of Regulation (EU) 2017/746 and are therefore not CE-marked as IVDs. They are supplied for animal health testing, research and surveillance use, and are manufactured under the same ISO 13485:2016 quality management system as the ViroGene human diagnostics range. Registration requirements for veterinary reagents vary by country.
- Quality management system
- ISO 13485:2016 — both manufacturing facilities
- Regulatory status
- Veterinary reagents; not CE-marked as in vitro diagnostic medical devices under Regulation (EU) 2017/746
- Intended use
- Animal health testing, surveillance and research use by trained laboratory personnel
- Standard configuration
- 100 reactions per kit; 50-reaction, bulk, lyophilised and OEM formats on request
- Storage and shipping
- Shipped on dry ice or cold packs as stated in each product insert; store at -20 °C unless otherwise specified
- Ordering
- Quote the full REF and the required pack size; minimum order quantities and lead times on request
- Availability
- Product availability and registration status vary by country; not all products are registered in all markets
Life Science — Research Use Only
Life Science products are labelled For Research Use Only. They are not intended for use in diagnostic procedures and carry no CE-IVD marking under Regulation (EU) 2017/746.
ISO 13485:2016 certified manufacturing. Research Use Only products are manufactured under the same documented process controls as ViroGene's CE-marked in vitro diagnostic assays, without IVDR conformity assessment or clinical performance claims.