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On this page you will find order codes, technical specifications and documents for the selected product.
|Product name||Catalog no.||Technology||Packaging|
|GeneProof SARS-CoV-2 Screening PCR Kit||COV2S/MC/190||real-time PCR||190 qualitative tests|
|Indication||in vitro diagnostic medical device|
|Regulatory Status||CE IVD / EC Directive 98/79/EC|
|Intended User||For professional use in laboratories with trained staff|
|Test Principle||reverse transcription real-time polymerase chain reaction (PCR)|
|Type of Analysis||Qualitative|
|Automated / Manual detection||Automated|
|Target sequence||RdRp, E and N genes|
|Analytical Specificity||SARS-CoV-2, 100 %|
|Analytical Sensitivity (LoD with 95% Probability)||
|myCROBE/croBEE 2.0 Universal Extraction Kit||138,33 cp/mL||FAM||PBS|
myCROBE Universal Internal Control
|Validated Specimen||swab, transport medium|
|Storage||-20 ± 5 °C|
|Validated Extraction Methods||myCROBE/croBEE 2.0 Universal Extraction Kit|
myCROBE® Fully Automated Instrument
|Detection Channels||FAM (SARS-CoV-2), HEX (IC)|
|External Quality Assessment||Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com|