CE Marked Blood Grouping Reagents, are available as a distinct range of products from Rapid Labs to meet the demands of our clients that require a Free Sale Certificate and or a CE Certificate as specified by their own regional registration system or for supply into the European Union Markets.
CE Marked Blood Grouping Reagents for ABOD fall into one of the most highly regulated classes of diagnostic reagents, currently the regulations concerning their production fall under the EU IVD Directive, this is being replaced by the IVDR with final implementation having approximately 4 years before it is fully implemented.
The cost to comply with this most stringent regulation is high due to the high level of notified body involvement from the Product file assessment to the annual audits, unscheduled audits and batch/lot release testing and supervision. As a result the selling price of the CE Mark reagent is higher than the Non CE Mark equivalent.
We are proud to offer 2 versions of our CE-Marked blood grouping reagents which consists of additional clones; ideal for markets that require testing from two different formulations. Our newest range is available for immediate delivery and at a lower price, whilst our original range is suited to a greater range of techniques, such as Microplate. For pricing information please contact us at medical@rapidlabs.co.uk
| Product Code Prefix | BG- | BC- |
| CE-Marked | Yes | Yes |
| Delivery | Immediate | 6-8 Weeks |
| Lower Price | Yes | No |
| Suitable Methods | Tube, DiaMed-ID and Slide technique | Tube, DiaMed-ID, Ortho BioVue, Microplate and Slide techniques |
