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GeneProof PathogenFree DNA 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 DNA isolation
  • One extraction procedure for various types of biological materials
  • Suitable also for human genetic diagnostics

PATHOGEN-FREE DESIGN

  • Special column design avoiding microbial contamination

Order information

Product name Catalog no. Technology Packaging
GeneProof PathogenFree DNA Isolation Kit IDNA050 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 200 µl
Elution Sample Volume 50 µl / 100 µl
Average Yield (4 – 6) µg
Binding Capacity 60 µg
A260/280 Ratio 1.60 – 1.90
Concentration (40 – 60) ng/µl
Extraction Control Extraction efficiency control by Universal Internal Control (UNIC) / Internal Control (IC) or Internal Standard (IS)
Validated Specimen Whole blood, plasma, serum, cerebrospinal fluid (CSF), urine, sputum, bronchoalveolar lavage (BAL), aspirate, sperm, tick, saliva, swab

Documentation

Instruction for Use

; GP_IDNA_Advisory_Notice_08_22_EN
pdf, [846.92 kB]
; GP_IDNA_Instruction_for_Use_EN
pdf, [279.91 kB]

Declaration of Conformity

; GP_IDNA050_Declaration_of_Conformity_EN
pdf, [877.14 kB]

MSDS

; GP_IDNA_Safety Data Sheet_EN
pdf, [1.09 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!