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GeneProof PathogenFree RNA Isolation Kit

CE IVD IVDR

PRODUCT ADVANTAGES

 

IVDR CERTIFIED

  • Complies with the IVDR Regulation (EU) 2017/746 

ONE EXTRACTION – VARIOUS SPECIMENS

  • Universal, user friendly, efficient and quick RNA isolation
  • One extraction procedure for various types of biological materials

PATHOGEN-FREE DESIGN

  • Special column design avoiding microbial contamination

Order information

Product name Catalog no. Technology Packaging
GeneProof PathogenFree RNA Isolation Kit IRNA050 membrane column kit 50 isolations
INSTRUCTIONS FOR USE/ e-IFU

Product Leaflet

Product Leaflet

; GP_IRNA_Product Leaflet_EN
pdf, [604.27 kB]
Choose all

Technical specification

Indication Accessory to in vitro diagnostic medical device
Regulatory Status CE IVD / EU Regulation 2017/746
Intended User For professional use in laboratories with trained staff
Initial Sample Volume up to 150 µl
Elution Sample Volume 50 µl
Typical Recovery Rates > 90 %
Typical Analysis Limit (30 – 60) cp/ml
Binding Capacity 40 µg
Time / Extraction 30 min / 4 – 6 extractions
Extraction Control Extraction efficiency control by Universal Internal Control (UNIC) / Internal Control (IC) or Internal Standard (IS)
Validated Specimen Plasma, serum, swab, bronchoalveolar lavage (BAL), aspirate, cerebrospinal fluid (CSF)

Instructions for Use

; GP_IRNA_Advisory_notice_05_22_EN
pdf, [532.36 kB]
; GP_IRNA_Advisory_Notice_EN
pdf, [532.36 kB]
; GP_IRNA_Declaration of Usability for SARS-CoV-2 extractions
pdf, [116.75 kB]
; GP_IRNA_Instruction_for_Use_EN
pdf, [452.43 kB]

Declaration of Conformity

; GP_IRNA_Declaration_of_Conformity_EN
pdf, [870.97 kB]

MSDS

; GP_IRNA_Safety Data Sheet_EN
pdf, [1.52 MB]
Files are available only for registered users.

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