Home / Device Screening / Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400 / MDIR-0002415
DRAP registered medical device · imported

Elecsys Anti SARS-CoV-2 Test Kit

Class C (moderate to high risk) · MDIR-0002415 · Roche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400

✓ DRAP status Renewal due Renewal date passed 31 Mar 2026
Screened against DRAP's published lists

DRAP REGISTERED MEDICAL DEVICE

Elecsys Anti SARS-CoV-2 Test Kit (Antibody Kit) is registered with DRAP under number MDIR-0002415 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 (31 Mar 2026) has passed, so ask the supplier for the renewal letter.

Screening result

i
Imported device, registered with DRAP as Class C (moderate to high risk)
MDIR-0002415 · 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
!
Renewal date passed on 31 Mar 2026
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
✓
Holder has a DRAP import licence on file
ELI-00009
DeviceElecsys Anti SARS-CoV-2 Test Kit (Antibody Kit)
ClassC
Listed holderRoche Pakistan Ltd. 1st Floor, 37-B, Block-6, P.E.C.H.S, Karachi East 75400
Holder addressGodown: R-Pl, Plot No. 56, Sector 15, K.I.A, Karachi
Manufacturing siteM/s Roche Diagnostics GmbH Sandhofer Str.116 68305 Mannheim Germany
Issued1 Apr 2021
Renewal date31 Mar 2026
LicenceELI-00009

Specifications

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Screened 7 Oct 2026, 04:08 (Pakistan time). A screening aid, not an official DRAP verification.

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MDIR-0001252Cobas Elecsys Anti-HAV Test KitClass C
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Similar devices from other companies

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

MDIR-0009939Elecsys Anti-HBs III [09810471190 09810480190 09810501190]Class DRoche Pakistan Ltd.
MDIR-0009312Elecsys Anti-HEV IgM Test KitClass CRoche Pakistan Ltd.
MDIR-0009313Elecsys Anti-HEV IgG Test KitClass CRoche Pakistan Ltd.
MDIR-0009318Elecsys Anti-HAV IgMClass CRoche Pakistan Ltd.
MDIR-0006815Elecsys Anti-p53 Test KitClass CRoche Pakistan Ltd.
MDIR-0002475Cobas Elecsys Thyroid antibodies and Anti-CCP ClusterClass BRoche Pakistan Ltd.
MDIR-0000189Cobas Elecsys Anti-HBe KitClass DRoche Pakistan Ltd.
MDIR-0000191Cobas Elecsys Anti-HBc IgM KitClass DRoche Pakistan Ltd.
MDIR-0000193Cobas Elecsys Anti-HBs KitClass DRoche Pakistan Ltd.
MDIR-0000040Elecsys Anti HCV II KitClass DRoche Pakistan Ltd.37-C, Block -6, P.E.C.H.S, Karachi

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.