DRAP REGISTERED MEDICAL DEVICE
Healgen HCV Hepatitis C Virus Rapid Test (Serum/Plasma) (Cassette) Healgen HCV Hepatitis C Virus Rapid Test (Whole blood/Serum/Plasma) (Cassette) is registered with DRAP under number MDIR-0004992 as a Class D (high risk) medical device, imported. The listed holder is Shams Scientific Traders. It is listed as valid until 2 Apr 2028.
Screening result
MDIR-0004992 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00459
| Device | Healgen HCV Hepatitis C Virus Rapid Test (Serum/Plasma) (Cassette) Healgen HCV Hepatitis C Virus Rapid Test (Whole blood/Serum/Plasma) (Cassette) |
|---|---|
| Class | D |
| Listed holder | Shams Scientific Traders |
| Holder address | Office No 7, First Floor Sadiq Plaza, P-481-Jinnah Colony, Faisalabad |
| Manufacturing site | M/s Healgen Scientific LLC 3818 Fuqua Street, Houston, TX 77047, USA M/s Zhejiang Orient Gene Biotech Co., Ltd., 3787#, East Yangguang Avenue, Dipu street Anji 313300 Huzhou, Zhejiang, China |
| Issued | 3 Apr 2023 |
| Renewal date | 2 Apr 2028 |
| Licence | ELI-00459 |
Specifications
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Screened 6 Oct 2026, 07:05 (Pakistan time). A screening aid, not an official DRAP verification.
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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.