DRAP REGISTERED MEDICAL DEVICE
Wondfo (One Step Dengue NS1 Antigen whole blood/serum/ plasma Test) is registered with DRAP under number MDIR-0005646 as a Class C (moderate to high risk) medical device, imported. The listed holder is Taj Diagnostics. It is listed as valid until 19 Oct 2028.
Screening result
MDIR-0005646 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00589
| Device | Wondfo (One Step Dengue NS1 Antigen whole blood/serum/ plasma Test) |
|---|---|
| Class | C |
| Listed holder | Taj Diagnostics |
| Holder address | Shop No. G-166, Maryam Market, M.A. Jinnah Road, Saddar, Karachi. |
| Manufacturing site | M/s Guangzhou Wondfo Biotech Co., Ltd., No. 08 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. China |
| Issued | 20 Oct 2023 |
| Renewal date | 19 Oct 2028 |
| Licence | ELI-00589 |
Specifications
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Screened 5 Oct 2026, 12:51 (Pakistan time). A screening aid, not an official DRAP verification.
More devices from this holder
Other DRAP registrations and enlistments listed for the same company.
| MDIR-0005637 | HemoSmart GOLD (Hemoglobin Screening Meter) | Class C |
| MDIR-0005638 | HemoSmart GOLD (Hemoglobin Test Strips) | Class C |
| MDIR-0005639 | UASure II (Blood Uric Acid Monitoring system) | Class C |
| MDIR-0005640 | UASure II (Blood Uric Acid Test Strip) | Class C |
| MDIR-0005641 | GlucoSure Star Strips (Blood Glucose Strips) | Class C |
| MDIR-0005642 | UASure (Blood Uric Acid Test Strip) | Class C |
| MDIR-0005643 | Wondfo (One Step Dengue IgG/IgM whole blood/serum/ plasma Test) | Class C |
| MDIR-0005644 | Wondfo (One Step Troponin I whole blood/serum/ plasma Test) | Class C |
| MDIR-0005645 | Wondfo (Combined Diagnostic Kit for Dengue NS1 Antigen and IgG/IgM antibody (colloidal gold) | Class C |
| MDIR-0005647 | Genesign Novel Corona Virus (2019-nCoV) Antigen Testing Kit (Lateral Flow Assay) | Class C |
| MDIR-0005648 | InTec (One Step Anti-TP (Treponema Pallidum/Syphillis) Test) | Class C |
| MDIR-0005649 | InTec One Step Anti-Dengue (IgM/IgG) Tri-Line Test) | Class C |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0002579 | Wondfo 2019-nCoV Antigen Test Device (Lateral Flow Method) [W196] | Class C | Schazoo SPL Consumer Healthcare |
| MDIR-0002580 | Wondfo 2019-nCoV Real Time-RT PCR Assay kit [W275P002] | Class C | Schazoo SPL Consumer Healthcare |
Corrections
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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.