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GeneProof Mycoplasma genitalium 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 Mycoplasma genitalium MC PCR Kit MG/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
Test Principle Real-time polymerase chain reaction (PCR)
Type of Analysis Qualitative
Automated / Manual detection Automated
Target sequence A multicopy sequence of the gene encoding the 16S rRNA
Analytical Specificity Mycoplasma genitalium (MG), 100 %
Analytical Sensitivity (LoD with 95% Probability)
Sensitivity Material Culture Quantified by
1355.71 cp/ml swab ATCC Mycoplasma genitalium Amplirun® Mycoplasma genitalium DNA control, Vircell
377.07 cp/ml urine ATCC Mycoplasma genitalium Amplirun® Mycoplasma genitalium DNA control, Vircell
Extraction/Inhibition Control

myCROBE Universal Internal Control

Validated Specimen Swab, urine
Storage -20 ± 5 °C
Validated Extraction Methods myCROBE/croBEE 2.0 Universal Extraction Kit
Instruments

myCROBE® Fully Automated Instrument

Detection Channels FAM (MG), HEX (IC)
External Quality Assessment Regularly tested in QCMD External Quality Assessment Panels - results at www.geneproof.com

Documentation

Instruction for Use

GP_MC_MG_Instruction_for_Use_EN
pdf, [258.42 kB]

Declaration of Conformity

GP_EC_Full_Quality_Assurance_Certificate_EN
pdf, [417.58 kB]
Files are available only for registered users.

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