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GeneProof Treponema pallidum MC PCR Kit

CE IVD myCROBE® line

On this page you will find order codestechnical specifications and documents for the selected product.

Order information

Product name Catalog no. Technology Packaging
GeneProof Treponema pallidum MC PCR Kit TP/MC/190 PCR for 180 quantitative tests

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
Type of Analysis Qualitative
Target Sequence Gene polA encoding DNA polymerase I
Analytical Specificity Treponema pallidum, 100 %
Analytical Sensitivity
(LoD with 95% probability)
1.73 cp/µl (performed on Amplirun® Treponema pallidum DNA control, Vircell)
Extraction/Inhibition Control Internal control by myCROBE Universal Internal Control
Validated Specimen

Swab, urine

Storage Conditions

(-20 ± 5) °C

Validated Extraction Methods myCROBE/croBEE 2.0 Universal Extraction Kit
Applied Instruments

myCROBE® Fully Automated Instrument

Detection Channels FAM (TP), HEX (IC)
External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

 

Documentation

Instruction for Use

; GP_MC_TP_Instruction for use_EN
pdf, [268.92 kB]

Declaration of Conformity

; GP_MC_TP_Declaration of conformity_EN
pdf, [561.37 kB]
Files are available only for registered users.

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