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GeneProof Team
myCROBE® line
On this page you will find order codes, technical specifications and documents for the selected product.
| Product name | Catalog no. | Technology | Packaging |
| GeneProof Factor XIII V34L MC PCR Kit | FXIII/MC/200 | PCR | for 180 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 | Real-time polymerase chain reaction (PCR) | |
| Type of Analysis | Qualitative | |
| Automated / Manual detection | Automated | |
| Target | G103T Polymorphism of the gene F13A1 (V34L) | |
| Specificity | Single nucleotide guanine/thymine polymorphism in the gene F13A1 in site 103 (G103T) | |
| Concentration Range | 10-90 ng/µl | |
| Negative Percentage Agreement | 100 % (CI95%: 93,05 % - 100 %) | |
| Positive Percentage Agreement | 100 % (CI95%: 89,79 % - 100 %) | |
| Overall Percentage Agreement | 100 % (CI95%: 95,72 % - 100 %) | |
| Validated Specimen | Whole blood | |
| Validated Extraction Methods | myCROBE/croBEE 2.0 Universal Extraction Kit | |
| Instruments |
myCROBE® Fully Automated Instrument |
|
| Detection Channels | FAM, HEX | |
| External Quality Assessment | Tested in Reference Institute for Bioanalytics Quality Assessment Panels - results at www.geneproof.com |
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