Cobas HIV-1/HIV-2 Qualitative - DRAP MDIR-0003361 (Class D)

DRAP REGISTERED MEDICAL DEVICE

Cobas HIV-1/HIV-2 Qualitative (Kit) is registered with DRAP under number MDIR-0003361 as a Class D (high risk) medical device, imported. The listed holder is Roche Pakistan Ltd. It is listed as valid until 26 Apr 2027.

Screening result

i
Imported device, registered with DRAP as Class D (high risk)
MDIR-0003361 · the class is taken from DRAP's list for this number
✓
Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
✓
Listed valid until 26 Apr 2027
✓
Holder has a DRAP import licence on file
ELI-00009
DeviceCobas HIV-1/HIV-2 Qualitative (Kit)
ClassD
Listed holderRoche Pakistan Ltd
Holder address1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400
Manufacturing siteM/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.
Issued27 Apr 2022
Renewal date26 Apr 2027
LicenceELI-00009

Specifications

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Screened 6 Oct 2026, 11:41 (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-0000603IVD Instrument BenchMark Ultra System with AccessoriesClass A
MDIE-0000604Cobas C111 Analyzer (Without ISE)Class A
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MDIR-0001246Elecsys HSV-1 IgG Test KitClass C
MDIR-0001247Cobas Elecsys Everolimus Test KitClass C
MDIR-0001248Cobas Elecsys Tacrolimus Test KitClass C
MDIR-0001249Cobas Elecsys Sirolimus Test KitClass C
MDIR-0001250Cobas Elecsys Cyclosporine Test KitClass C
MDIR-0001251Cobas Elecsys PAPP-A Test KitClass C
MDIR-0001252Cobas Elecsys Anti-HAV Test KitClass C
MDIR-0001253Cobas Elecsys sFlt-1 Test KitClass C

Similar devices from other companies

Same device type listed by other holders, useful when comparing suppliers.

MDIR-0000184Cobas AmpliPrep/ Cobas TaqMan HCV Qualitative Test, v2.0Class DRoche Pakistan Ltd.
MDIR-0000190Cobas AmpliPrep/ Cobas TaqMan HIV-1 Qualitative Test, v2.0Class DRoche 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.