DRAP REGISTERED MEDICAL DEVICE
Cobas HCV Quantitative nucleic acid test kit (for use on Cobas 6800/8800 systems) is registered with DRAP under number MDIR-0000621 as a Class C (moderate to high risk) medical device, imported. The listed holder is Roche Pakistan Ltd.. Its listed renewal date (9 Oct 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000621
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 HCV Quantitative nucleic acid test kit (for use on Cobas 6800/8800 systems) |
|---|---|
| Class | C |
| Listed holder | Roche Pakistan Ltd. |
| Holder address | 37-C, Block -6, P.E.C.H.S, Karachi, 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 M/s Roche Molecular System Inc 1080 US Hwy 202, South Branchburg, NJ 08876 USA |
| Issued | 9 Nov 2019 |
| Renewal date | 9 Oct 2024 |
| Licence | ELI-00009 |
Specifications
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Screened 5 Oct 2026, 00:35 (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 |
| MDIE-0000599 | Cobas b 121 system | Class A |
| 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 |
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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.