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GeneProof Team
GROUP INFORMATION | |
Indication | in vitro diagnostic medical devices |
Regulatory Status | CE IVD |
Intended User | For professional use in laboratories with trained staff |
Test Principle | Real-time PCR |
Automated / Manual detection | Automated |
Extraction / Inhibition Control | Internal Control by myCROBE Universal Internal Control |
Validated Extraction Method | myCROBE/croBEE 2.0 Universal Extraction Kit |
Instrument | myCROBE Fully Automated Instrument |
GROUP INFORMATION | |
Indication | in vitro diagnostic medical devices |
Regulatory Status | CE IVD |
Intended User | For professional use in laboratories with trained staff |
Test Principle | Real-time PCR |
Automated / Manual detection | Automated |
Extraction / Inhibition Control | Internal Control by myCROBE Universal Internal Control |
Validated Extraction Method | myCROBE/croBEE 2.0 Universal Extraction Kit |
Instrument | myCROBE Fully Automated Instrument |
GROUP INFORMATION | |
Indication | in vitro diagnostic medical devices |
Regulatory Status | CE IVD |
Intended User | For professional use in laboratories with trained staff |
Test Principle | Real-time PCR |
Automated / Manual detection | Automated |
Validated Extraction Method | myCROBE/croBEE 2.0 Universal Extraction Kit |
Instrument | myCROBE Fully Automated Instrument |
GROUP INFORMATION | |
Indication | in vitro diagnostic medical devices |
Regulatory Status | CE IVD |
Intended User | For professional use in laboratories with trained staff |
Test Principle | Real-time PCR |
Function | Diagnostics, aid to diagnosis and screening |
What is detected / Target | SARS-CoV-2 |
Automated / Manual detection | Automated |
Type of Analysis | Qualitative |
Validated Specimen | Swab, transport medium |
Targer Sequence | RdRp, N and E genes |
Analytical Specificity | SARS-CoV-2, 100% |
Analytical Sensitivity | 138,33 cp/ml (transport medium: PBS) |
Extraction / Inhibition Control | Internal Control by myCROBE Universal Internal Control |
Validated Extraction Method | myCROBE/croBEE 2.0 Universal Extraction Kit |
Instrument | myCROBE Fully Automated Instrument |
External Quality Assessment | Tested in QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com |
+420 543 211 679
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+420 730 176 222
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GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens
Our products’ quality, safety, and performance are fully compliant with the new rules for in vitro…