DRAP REGISTERED MEDICAL DEVICE
Elecsys HSV-1 IgG Test Kit is registered with DRAP under number MDIR-0001246 as a Class C (moderate to high risk) medical device, imported. The listed holder is Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400. Its listed renewal date (5 Feb 2025) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0001246 · 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 HSV-1 IgG Test Kit |
|---|---|
| Class | C |
| Listed holder | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| Holder address | Godown: R-Pl, Plot No. 56, Sector 15, K.I.A, Karachi |
| Manufacturing site | M/s Roche Diagnostics GmbH Sandhofer Str.116, 68305 Mannheim, Germany |
| Issued | 6 Feb 2020 |
| Renewal date | 5 Feb 2025 |
| Licence | ELI-00009 |
Specifications
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Screened 6 Oct 2026, 02:24 (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.
| MDIE-0000603 | IVD Instrument BenchMark Ultra System with Accessories | Class A |
| MDIE-0000604 | Cobas C111 Analyzer (Without ISE) | Class A |
| MDIR-0001244 | Cobas BRAF, Mutation Test | Class C |
| MDIR-0001245 | Cobas Elecsys CMV IgM Test Kit | Class C |
| MDIR-0001247 | Cobas Elecsys Everolimus Test Kit | Class C |
| MDIR-0001248 | Cobas Elecsys Tacrolimus Test Kit | Class C |
| MDIR-0001249 | Cobas Elecsys Sirolimus Test Kit | Class C |
| MDIR-0001250 | Cobas Elecsys Cyclosporine Test Kit | Class C |
| MDIR-0001251 | Cobas Elecsys PAPP-A Test Kit | Class C |
| MDIR-0001252 | Cobas Elecsys Anti-HAV Test Kit | Class C |
| MDIR-0001253 | Cobas Elecsys sFlt-1 Test Kit | Class C |
| MDIR-0001254 | Cobas Elecys AntiHAV IgM Test Kit | Class C |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0009945 | Elecsys IGFBP-3 Test Kit | Class B | Roche Pakistan Ltd. |
| MDIR-0009947 | Elecsys Cortisol III Urine Test Kit | Class B | Roche Pakistan Ltd. |
| MDIR-0009873 | Elecsys CEA [CAT #: 09755616190 Pack size: 100 Tests CAT #: 04491777190 Pack size: 200 Tests… | Class C | Roche Pakistan Ltd. |
| MDIR-0009874 | Elecsys Ferritin [CAT #: 09755667190 Pack size: 100 Tests CAT #: 03737551214 Pack size: 100 Tests… | Class B | Roche Pakistan Ltd. |
| MDIR-0009875 | Elecsys Vitamin B12 II [CAT #: 09755896190 Pack size: 100 Tests CAT #: 07028121214 Pack size:… | Class B | Roche Pakistan Ltd. |
| MDIR-0009876 | Elecsys free PSA [CAT #: 09744908190 Pack size: 100 Tests CAT #: 08828610214 Pack size: 300… | Class C | Roche Pakistan Ltd. |
| MDIR-0009878 | Elecsys Rubella IgM [CAT #: 09755837190 Pack size: 100 Tests] | Class C | Roche Pakistan Ltd. |
| MDIR-0009879 | Elecsys PIVKA-II [CAT #: 09652043190 Pack size: 100 Tests] | Class C | Roche Pakistan Ltd. |
| MDIR-0009880 | Elecsys SHBG [CAT #: 09744495190 Pack size: 100 Tests] | Class B | Roche Pakistan Ltd. |
| MDIR-0009881 | Elecsys Toxo IgM [CAT #: 09755861190 Pack size: 100 Tests] | Class C | Roche 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.