DRAP REGISTERED MEDICAL DEVICE
Mycobacterium Tuberculosis IgM (ELISA kit) [DETUB03 96 wells] is registered with DRAP under number MDIR-0001620 as a Class C (moderate to high risk) medical device, imported. The listed holder is Future Scientific. Its listed renewal date (22 Jul 2025) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0001620 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
ELI-00209
| Device | Mycobacterium Tuberculosis IgM (ELISA kit) [DETUB03 96 wells] |
|---|---|
| Class | C |
| Listed holder | Future Scientific |
| Holder address | FS House, Opposite Street No 4, Main Road, Shaheen Town, Gangal West, Rawalpindi., Godown Address:Same as above |
| Manufacturing site | M/s Demeditec Diagnostics GmbH Lise-Meitner-StraBe 2, D-24145 Kiel, Germany |
| Issued | 23 Jul 2020 |
| Renewal date | 22 Jul 2025 |
| Licence | ELI-00209 |
Specifications
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Screened 6 Oct 2026, 16:44 (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-0006676 | GeneProof Mycobacterium tuberculosis PCR Kit | Class C | Med Lab 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. |
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.