Korea MFDS Approval
Genetic & Precision Medicine
MoiM HLA-B27 Detection Kit
Korea MFDS Approval
Category
| Intended Use | A real-time polymerase chain reaction (Real-time PCR) in vitro diagnostic medical device intended for the qualitative detection of HLA-B27, one of the alleles of the HLA-B gene, in genomic DNA isolated from human EDTA-treated whole blood specimens, to aid in the diagnosis of ankylosing spondylitis. |
| Target Genes | HLA-B*27 |
| Sample Types | EDTA Whole Blood |
| Sample Volume | 150 uL |
| LoD | 0.02 ng/µL. |
| Specificity | 100% |
| Turnaround Time | 90min |