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Awarded20/06/2014
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Today17/09/2026
Utilities
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Germany-Kiel: Veterinary services
A test system is needed to detect the ERNs antigen from BVDV from blood samples (serum or plasma) and tissue samples, e.g. ear sticks. The test is authorised by the approval body of the FLI in accordance with § 17c(1) TierSG. The FLI’s official collection of methods allows the use of the test as part of the BVDV control Regulation.
The test system can be used in a commercial automation process, but allows manual processing.
A batch-specific marking of all components of the test system is provided.
The test is approved for testing serum, plasma and tissue samples, in particular ear-stick samples.
2. Laboratory specific conditions:
Solutions contained in the kit such as conjugate and substrate must be ready for use. The quantity of such solutions supplied per kit shall take into account the increased dead volume in machine-based processing compared to manual methods. The solutions to be used must be usable at room temperature.
The processing protocol shall ensure that all samples taken using any of the collection systems currently on the market can be analysed.
3. Testing of proposed batches:
The batches offered must be released by the approval body of the Friedrich Löffler Institute (FLI).
Specific suitability will be checked in-house under the laboratory-specific conditions of the Land laboratory. The test procedure and the nature and reproducibility of the test results are considered on the basis of the examination of a sample batch selected by the Land laboratory.
The quantity of test kits available to LSH after the award should be so large that it meets the requirements for at least 20000 individual tests. If one batch does not meet the criteria, it may be returned and replaced for another.
The results of the audit are not countervailable.
85200000 - Veterinary services
33600000 - Pharmaceutical products
33696000 - Reagents and contrast media
33690000 - Various medicinal products
33000000 - Medical equipments, pharmaceuticals and personal care products
Postal address: Mörikestr. 28/3
Town: Ludwigsburg
Postal code: 71636
Country: DEU
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