DRAP REGISTERED MEDICAL DEVICE
Cobas Elecsys Cyclosporine Test Kit is registered with DRAP under number MDIR-0001250 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-0001250 · 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 | Cobas Elecsys Cyclosporine 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, 00:19 (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-0001246 | Elecsys HSV-1 IgG 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-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-0005584 | COBAS Elecsys HSV-2 IgG Test Kits [05572193190, 07027508190] | Class C | Roche Pakistan Ltd. |
| MDIR-0004716 | Roche Cobas Elecsys IL-6 Assay | Class B | Roche Pakistan Ltd. |
| MDIR-0004618 | Roche Cobas Elecsys IL-6 Assay cluster | Class B | Roche Pakistan Ltd. |
| MDIR-0004464 | COBAS Elecsys Troponin T HS Test Kit. | Class C | Roche Pakistan Ltd. |
| MDIR-0003707 | Cobas Elecsys PIVKA II Test Kit | Class C | Roche Pakistan Ltd. |
| MDIR-0003212 | Cobas Elecsys Fertility Markers | Class B | Roche Pakistan Ltd. |
| MDIR-0002475 | Cobas Elecsys Thyroid antibodies and Anti-CCP Cluster | Class B | Roche Pakistan Ltd. |
| MDIR-0002478 | COBAS Elecsys IgE-II (Allergy Panel). IVD-Cluster | Class B | Roche Pakistan Ltd. |
| MDIR-0000628 | Cobas Elecsys Total PSA | Class C | Roche Pakistan Ltd. |
| MDIR-0000629 | Cobas Elecsys Syphilis test kit | Class C | 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.
