DRAP REGISTERED MEDICAL DEVICE
Cobas HIV-1 (Cobas 6800) Cobas NHP Negative Control Kit is registered with DRAP under number MDIR-0004248 as a Class C (moderate to high risk) medical device, imported. The listed holder is Roche Pakistan Ltd.. It is listed as valid until 1 Dec 2027.
Screening result
MDIR-0004248 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00009
| Device | Cobas HIV-1 (Cobas 6800) Cobas NHP Negative Control Kit |
|---|---|
| Class | C |
| Listed holder | Roche Pakistan Ltd. |
| Holder address | 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| Manufacturing site | M/s Roche Diagnostics GmbH Sandhofer Strasse 116, 68305 Mannheim Germany. M/s Roche Molecular Systems Inc., 1080 US Hwy 202, South Branchburg, NJ 08876 USA |
| Issued | 2 Dec 2022 |
| Renewal date | 1 Dec 2027 |
| Licence | ELI-00009 |
Specifications
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Screened 5 Oct 2026, 13:52 (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-0000598 | Cobas 6800 system | Class A |
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| MDIE-0000600 | Cobas 6000 Analyzer series (system) | Class A |
| MDIE-0000601 | Cobas c311 Analyzer with IVD consumables | Class A |
| MDIE-0000602 | Cobas PCR Media Dual Swab Sample Kit [Cobas PCR Media Dual Swab Sample Kit Code: 07958021190… | Class A |
| MDIE-0000622 | 9180 Electrolyte Analyzer [03157334001 Size: 1 Unit] | Class A |
| MDIE-0000623 | Cobas TaqScreen Wash Reagent [04404220190] | Class A |
| MDIE-0000624 | PYP (Pyridoxal Phosphate) [08062986190 Size: 950 Tests ] | Class A |
| MDIE-0000625 | Cobas Omni Utility Channel Reagent Kit [09052011190] | Class A |
| MDIE-0000626 | Cobas p501 post-analytical unit [05158494001] | Class A |
| MDIE-0000627 | Cobas b 101 system [06378668190 Pack size: One Unit] | Class A |
| MDIE-0000628 | Cobas PCR Urine | Class A |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIE-0000604 | Cobas C111 Analyzer (Without ISE) | Class A | Roche Pakistan Ltd |
| MDIE-0000605 | Cobas pro Integrated solution (system) | Class A | Roche Diagnostics GmbH |
| MDIR-0003361 | Cobas HIV-1/HIV-2 Qualitative (Kit) | Class D | Roche Pakistan Ltd |
| MDIR-0001244 | Cobas BRAF, Mutation Test | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001245 | Cobas Elecsys CMV IgM Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001247 | Cobas Elecsys Everolimus Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001248 | Cobas Elecsys Tacrolimus Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001249 | Cobas Elecsys Sirolimus Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001250 | Cobas Elecsys Cyclosporine Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
| MDIR-0001251 | Cobas Elecsys PAPP-A Test Kit | Class C | Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 |
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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.