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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

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)

Documentation

Instruction 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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IVDR products available!

All our Class „A“ products are now IVDR certified as required since May, 2022. Let’s see our offer!