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EC CERTIFICATE

EC Declaration of Conformity Annex (List B)

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CERTIFICATE ISO 13485

InterLabService
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AmpliSens
AmpliSens MRSA-screen-titre-FRT
Cat.: R-B78-100-FT(RG,iQ)-CE
Name: AmpliSens MRSA-screen-titre-FRT
Number of tests: 110
Detection Method: FRT
Packaging arrangement (PA): Kit with reagents only for amplification step
Content: All reagents are in individual vials (no PCR-tubes) + Taq-F polymerase (hot start)
Type: Non-aliquoted
Shelf life: 9 months

Information bulletin AmpliSens MRSA-screen-titre-FRT PCR kit (version 12.12.2018, update: 17.12.2018)
AmpliSens MRSA-screen-titre-FRT PCR kit Instruction Manual (update 22.07.2021)
Guidelines to AmpliSens MRSA-screen-titre-FRT PCR kit (update 28.07.2021)


AmpliSens MRSA-screen-titre-FRT PCR kit is an in vitro nucleic acid amplification test for qualitative and quantitative detection of methicillin-sensitive and methicillin-resistant Staphylococcus aureus DNA and methicillin-resistant coagulase-negative Staphylococcus spp. DNA in the biological material (oropharyngeal swabs, bronchoalveolar lavage (BAL), sputum, endotracheal aspirate, bronchial washing fluid, urine (first portion pellet), blood, blood plasma, cerebrospinal fluid (CSF), affected organs and tissues aspirates, washes from healthcare equipment and instruments) using real-time hybridization-fluorescence detection.

Recommended extraction kit: RIBO-prep (K2-9-Et-100-CE). It is possible to use other nucleic acid extraction protocols.

Adapted for:

  • Rotor-Gene 3000, Rotor-Gene 6000 (Corbett Research, Australia)
  • Rotor-Gene Q (QIAGEN, Germany)
  • iCycler iQ5 (Bio-Rad, USA)

 
Attention!!! Number of tests includes controls and calibrators (for quantitative tests).

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