*USAGE / SAFETY STATEMENT
This product is for research or laboratory use only and are not to be administrated to humans. This product is not intended for medical diagnostic or therapeutic use.
DISCLAIMER
Labscoop LLC and/or Kaneka Eurogentec S.A.'s liability shall be limited strictly to the replacement of non-compliant products or to the reimbursement of their price, at Labscoop LLC and/or Kaneka Eurogentec S.A.'s sole election. To the full extent permissible under the applicable legislation Labscoop LLC nor Kaneka Eurogentec S.A. may not be held liable for any cost or liability arising from or in connection with this product, including damages or accidents to persons, damages to goods other than this product sold, loss of earnings or profits, harm to reputation, or any other prejudice arising directly or indirectly from the product, and including defective products. IN NO EVENT SHALL LABSCOOP LLC OR KANEKA EUROGENTEC S.A. BE LIABLE UNDER THIS AGREEMENT FOR ANY PUNITIVE, EXEMPLARY, INDIRECT OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS. This product ordered by the customer are exclusively intended for laboratory research purposes and shall correspond to the quality and safety standards in accordance with said research purposes. This product shall not be used by the customer for any other purposes such as (the list is not exhaustive) diagnostic, prophylactic, therapeutic, cosmetic, commercial ends, or as food, ingredients or medical devices. Labscoop LLC and Kaneka Eurogentec S.A. shall accept no liability if the customer who ordered this product, intended exclusively for laboratory research, uses this product for purposes other than for research.
QUALITY CERTIFICATION / COMPLIANCE
Eurogentec Quality Management System is ISO 9001 certified by BSI under certificate number FS 638601. The certification applies to following activities: “Development, production and sales of products and services for research and development in life sciences”. Regulations for in vitro diagnostics (IVD) - Eurogentec manufactures products in support of in vitro diagnostic and related applications. The IVD medical device industry is regulated by FDA GMP/QSR (21 CFR Part 820), EU IVD Directive 98/79 EEC and EU 2017/746 Regulation. These regulations are not applicable to Eurogentec as it does not manufacture medical devices. However Eurogentec quality system is compliant to the applicable quality system requirements of these regulations.
KIT COMPONENTS
200 rxn kit contains: - One tube (1100 µL; white cap) containing IPC primers and YY-BHQ-1®probe - One tube (220 µL; red cap) containing IPC template DNA 1000 rxn kit contains: - Five tubes (1100 µL each; white cap) containing IPC primers and YY-BHQ-1®probe - One tube (1100 µL; yellow cap) containing IPC template DNA
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