Registered in IndonesiaTB Diagnostics · TB Diagnostic
EuDx MDR-TB Detection Kit
MDR-TB real-time PCR kit — MTB + RIF + INH in 65 minutes
- Brand
- EuDx
- Ingredients / technology
- SNP-based Multiplex Real-time PCR (TaqMan probes)
- Specification / packing
- 100 Tests / Box (Model TR-02-100)
- Certifications
- Kemenkes · KFDA (MFDS) · ISO 13485 · IVD Class C
- Indonesian licence
- AKL AKL 20303520830
- Class
- C
Order on KMEDIBIZ (members)
Prices are shown only to KMEDIBIZ members (verified doctors and clinics).
B2B enquiryIndonesian registration holder & distributor: PT Korea Medibiz Platform (NIB 1306240081869) IDAK · CDAKB · BPOM →
Product information
- Manufacturer
- Wizbiosolutions Inc., Republic of Korea
- Class
- In vitro diagnostic, Class C (real-time PCR kit)
- Model
- TR-02-100 · 100 tests / box
- Targets
- M. tuberculosis + rifampicin resistance + isoniazid resistance, detected together
- Target genes
- rpoB, katG, inhA, IS6110, mbp64 (internal control included)
- Limit of detection
- 100 copies/rxn (≈10–150 CFU/mL)
- Run time / specimen
- PCR 65 min (whole workflow <90 min) · sputum
- Clinical performance
- Agreement MTB 98.05% / RIF 95.35% / INH 96.05% (Chung-Ang University Hospital, 2019)
- Storage
- -20°C · IVD use only
- Approvals
- Kemenkes RI AKL 20303520830 (valid to 2028-09-28) · Korea MFDS · ISO 13485
B2B enquiry
Distributor, hospital or clinic? Send us your question — the K-MBSS team in Jakarta replies within 1–2 working days.
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