Quality & Certification
Validated and certified product quality.
Certifications & Licenses
ISO 9001
Quality management system.
ISO 13485
Medical device quality management system.
CPAKB
Good Manufacturing Practice for medical devices (local GMP for IVD).
Ministry of Health Registration (AKD/AKL)
Every product has a registration number listed in the product catalog.
E-Catalogue
All products are registered in the E-Catalogue.
TKDN
>60% for infectious disease RDTs, >50% for Drugs of Abuse.
Performance Validation
| Products | Sensitivity & Specificity | Validator |
|---|---|---|
| Malaria Pf/Pan Ag | 100% | RSP Unpad |
| Dengue IgG/IgM, NS1, Ag/Ab Combo | >80% | INA-Respond |
| HBsAg, HCV, HIV 1/2 | 100% | RSHS |
| Syphilis; HIV/Syphilis Combo | 100% | BBLK Jakarta; RSHS |
| Drug of Abuse (single & combo) | 100% | Labkesda DKI Jakarta |
| GBRapid G1 Glucose Strip | — | Laboratorium Kemenkes |
Need registration documents or IFU?
Download them from the product page or contact our team.
Open Catalog