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EC CERTIFICATE

EC Declaration of Conformity Annex (List B)

EC Declaration of Conformity Annex (Others)

CERTIFICATE ISO 13485

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AmpliSens
Amplisens Pseudomonas aeruginosa---FL
Cat.: H-1892-1-1
Name: Amplisens Pseudomonas aeruginosa---FL
Number of tests: 60
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 to AmpliSens Pseudomonas aeruginosa-screen-titre-FRT (version 12.12.2018, update: 17.12.2018)
AmpliSens Pseudomonas aeruginosascreen- titre-FRT PCR kit Instruction Manual (version 13.03.2019, update: 28.11.2019)
GUIDELINES to AmpliSens Pseudomonas aeruginosa-screentitre- FRT PCR kit (version 12.12.2018, update: 28.11.2019)


AmpliSens Pseudomonas aeruginosa-screen-titre-FRT PCR kit is an in vitro nucleic acid amplification test for qualitative detection and quantitation of the Pseudomonas aeruginosa DNA in the clinical material (blood, blood plasma, oropharyngeal swab, bronchoalveolar lavage (BAL), sputum, endotracheal aspirate, urine, prostatic secretion, cerebrospinal fluid, aspirate from lesions of organs and tissues) using real-time hybridization-fluorescence detection of amplified products.

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)
  • Mx3000P (Stratagene, USA)


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

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