DRAP REGISTERED MEDICAL DEVICE
Diagnostar HIV (Human Immunodeficiency Virus) Rapid Test Cassette (Serum /Plasma ) is registered with DRAP under number MDIR-0009485 as a Class D (high risk) medical device, imported. The listed holder is Gulf Marketing International. It is listed as valid until 25 May 2030.
Screening result
MDIR-0009485 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00194
| Device | Diagnostar HIV (Human Immunodeficiency Virus) Rapid Test Cassette (Serum /Plasma ) |
|---|---|
| Class | D |
| Listed holder | Gulf Marketing International |
| Holder address | 10B & 11B/2 Mohallah Satellite town, Abdullah Jan Masjid Street, Near Kali Tanki, Said Pur Road, Rawalpindi. |
| Manufacturing site | M/s Healgen Scientific Limited Liability Company 3818 Fuqua Street Houston USA M/s Zhejiang Orient Gene Biotech Co., Ltd. East Yangguang Avenue, Dipu Street Anji 313300 Huzhou Zhejiang, China |
| Issued | 26 May 2025 |
| Renewal date | 25 May 2030 |
| Licence | ELI-00194 |
Specifications
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Screened 5 Oct 2026, 22:59 (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-0009837 | Diagnostar HCV Ab Rapid Test Cassette (Serum/Plasma) 4 [GCHCV-302a] | Class D |
| MDIR-0009838 | Diagnostar Syphilis Ab Rapid Test (Cassette) (Serum /Plasma) [GCSYP-402a] | Class C |
| MDIR-0009839 | Diagnostar Toxoplasma gondii (Toxo)IgG/IgM Rapid Test (Cassette) (Serum/Plasma) [GCTOX-402a] | Class C |
| MDIR-0009840 | Diagnostar Typhoid IgG/IgM Rapid Test Cassette (Serum/Plasma) [GCTYP-302a] | Class B |
| MDIR-0009841 | Diagnostar Urinalysis Strips [URS-XXT] | Class B |
| MDIR-0009842 | Diagnostar HCG One Test Pregnancy Test Strip (urine) [GAHCG-101A] | Class B |
| MDIR-0009843 | Diagnostar Dengue NS1 Antigen Rapid Test (Whole blood, serum, plasma) [GCDEN(NS)-402c] | Class B |
| MDIR-0009844 | Diagnostar H.pylori Ab Rapid Test Cassette (Whole blood, serum , plasma) [GCHP-402a] | Class B |
| MDIR-0009845 | Diagnostar Tuberculosis IgG/IgM Rapid Test Cassete [GCTB-302a] | Class B |
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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.