DRAP REGISTERED MEDICAL DEVICE
Elecsys HBsAg II Kit is registered with DRAP under number MDIR-0000038 as a Class D (high risk) medical device, imported. The listed holder is Roche Pakistan Ltd.37-C, Block -6, P.E.C.H.S, Karachi. Its listed renewal date (25 Dec 2023) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000038 · 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-00009
| Device | Elecsys HBsAg II Kit |
|---|---|
| Class | D |
| Listed holder | Roche Pakistan Ltd.37-C, Block -6, P.E.C.H.S, Karachi |
| Holder address | Godown: R-Pl, Plot No. 56, Sector 15, K.I.A, Karachi |
| Manufacturing site | Manufacturer: M/s Roche Diagnostics GmbH Sandhofer Str.116, 68305 Mannheim, Germany |
| Issued | 26 Dec 2018 |
| Renewal date | 25 Dec 2023 |
| Licence | ELI-00009 |
Specifications
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Screened 6 Oct 2026, 20:39 (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-0000039 | Elecsys HIV Kit | Class D |
| MDIR-0000040 | Elecsys Anti HCV II Kit | Class D |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0006817 | Elecsys HBsAg II quant II Test Kit | Class D | Roche Pakistan Ltd. |
| MDIR-0006325 | Elecsys HBsAg Confirmatory Test | Class D | Roche Pakistan 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.