iFIND IFQ — Isoniazid and Fluoroquinolone Resistance Detection Kit
Manufacturer: Rocgene
Manufacturer-provided information All technical parameters below are manufacturer-provided information. Local regulatory status is not verified.
Product parameters
- Product type
- IVD Reagent Kit
- Intended use
- The iFIND IFQ (INH/FQs) Kit is intended for the detection of genetic mutations associated with resistance to isoniazid and fluoroquinolones.
Detection targets: Isoniazid resistance — katG, inhA; Fluoroquinolone resistance — gyrA.
Manufacturer-stated limit of detection: 100 CFU/mL.
Detection time: ≤120 minutes.
Amplification: Nested PCR with multiplex molecular beacon probe and melting curve analysis.
Sample types: Sputum (primary). specified for: BALF, pleural fluid, ascites, pus, CSF, gastric aspirate, urine, stool, tissue, and bacterial isolates.
Reagent storage: Lyophilized reagent beads, 2–28 °C.
Certification: CE-IVD (manufacturer-provided information, not independently verified).
NOTE: The same product (Cat. No. 10210102A/B) is referred to as "iFIND IFQ" in one manufacturer document and "iFIND MDR" in another. This naming conflict is documented and pending official clarification. - Certification claim
- Manufacturer-provided information. CE-IVD status not independently verified. Naming conflict (IFQ vs MDR) pending resolution. Manufacturer-provided information
- Product family
- iFIND Molecular Diagnostics Platform (iFIND)
- Manufacturer
- Rocgene
- Document status
- Partial
Market status
Local regulatory status not verified Local regulatory, import and service status per market. All fields default to "not checked" until independently verified.
| Market | Registration | Import | Evaluation | Commercial availability | Service | Local-language docs |
|---|---|---|---|---|---|---|
| Global (EN) Active | Not checked | Not checked | None | Not checked | Not checked | Missing |
| Russia (RU) | Not checked | Not checked | None | Not checked | Not checked | Missing |
| India (IN) | Not checked | Not checked | None | Not checked | Not checked | Missing |