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| Product Name | Lyme Disease IgG/IgM Self-Test – 10–15-Minute Result |
| Catalog No. | BI-QCY-0051 |
| Product Overview | A rapid qualitative immunoassay for detection of anti-Borrelia IgG and IgM antibodies. Designed for self-testing with a fingerstick whole-blood specimen; results should be interpreted with clinical context. |
| Applications | At-home preliminary screening for anti-Borrelia IgG/IgM antibodies; follow-up evaluation by a healthcare professional. |
| Certificate | CE, ISO 13485 |
| Detection Target | Anti-Borrelia IgG/IgM antibodies |
| Sample Type | Whole blood, serum, and plasma samples |
| Result Type | Qualitative (positive/negative) |
| Time to Result | 10-15 minutes |
| Specificity | >99% |
| Key Features | CE/IVD Marked — Fully compliant with European In Vitro Diagnostic Regulation (IVDR 2017/746) Rapid Results — Results available in 10–15 min Supplier-described accuracy; consult validation data — Sensitivity and specificity >99% Easy to Use — Clear instructions, no laboratory equipment required Quality Assured — Manufactured in ISO 13485 certified facilities |
For in vitro diagnostic use.
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