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BVD Tests Kit Approval

Test Kit users/ designated laboratories

The Irish BVD NRL provides for the evaluation of test kits for the diagnosis of BVD (tests for both antigen and antibody) by way of co-operation with the Friedrich Loeffler Institute (FLI), Insel Riems, Germany, the Federal Research Institute for Animal Health in Germany (http://www.fli.bund.de/en).

The test kit and individual batches thereof must be approved by FLI and listed as such on the FLI website or otherwise certified by FLI as approved for the purpose intended (with certification to batch level).

Designated laboratories must ensure that all testing carried out by them is via FLI-approved batches of test kits. Details of these test kits can be found at: 

http://www.fli.bund.de/en/startseite/services/licensing-authority.html

Designated laboratories are advised that they must retain copies of the batch approval from FLI for inspection by the NRL and/or Implementation Group.

 

Test Kit Manufacturers/Vendors

Manufacturers and vendors of test kits for BVD can find full information on how to apply for licensing and batch approval through the FLI website:

http://www.fli.bund.de/en/startseite/services/licensing-authority.html

All potential kit manufacturers are advised to read carefully the market licensing procedure and batch release procedure and make applications well in advance of anticipated release.