DRAP REGISTERED MEDICAL DEVICE
Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma) [GCTB-302a] is registered with DRAP under number MDIR-0003632 as a Class C (moderate to high risk) medical device, imported. The listed holder is Shams Scientific Traders. It is listed as valid until 15 Aug 2027.
Screening result
MDIR-0003632 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00459
| Device | Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma) [GCTB-302a] |
|---|---|
| Class | C |
| 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 | 16 Aug 2022 |
| Renewal date | 15 Aug 2027 |
| Licence | ELI-00459 |
Specifications
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Screened 6 Oct 2026, 02:40 (Pakistan time). A screening aid, not an official DRAP verification.
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Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0009845 | Diagnostar Tuberculosis IgG/IgM Rapid Test Cassete [GCTB-302a] | Class B | Gulf Marketing International |
| MDIR-0008025 | Medicare Tuberculosis Rapid Test | Class C | Mana & Co. |
| MDIR-0006476 | Realy (Tuberculosis Rapid Test Device) | Class C | MOODY Global Services |
| MDMR-000269 | R-test TB IgG/IgM Rapid Test (IgG, IgM anti-Mycobacterium tuberculosis (M. TB) detection kit) R-34050 | Class C | Lab Diagnostic Systems (SMC) Pvt. Ltd. |
| MDIR-0002598 | Abon TB Tuberculosis Rapid Test Device (whole blood/ Serum/ Plasma) Tuberculosis Test | Class C | Abbott Laboratories(Pakistan) Ltd |
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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.